Research Coordinator Clinical Research Resume Samples

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E Halvorson

Eldora

Halvorson

402 Jayden Springs

Dallas

+1 (555) 446 1314

402 Jayden Springs

Dallas

Phone

p +1 (555) 446 1314

Experience Experience

Boston, MA

Clinical Research Coordinator, RN

Boston, MA

Raynor-Fisher

Boston, MA

Clinical Research Coordinator, RN

Acts as liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol
In collaboration with the principal investigator, reviews studies for feasibility and evaluates potential competition with other protocols prior to submitting study
Reviews study with principal investigator to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator
Recruits and evaluates study patients, schedule appointments and interviews
Reviews medical records for potential study patients and ensures that medical records include documentation of all laboratory test results and procedures and progress of study patients, following guidelines set forth by the protocol sponsors
Assists investigator with consent process assuring study patients understand clinical trials and obtains written informed consent
Educates study patients concerning informed consent procedures, HIPAA authorization

Los Angeles, CA

Clinical Research Coordinator Hoag Inst for Research & Ed

Los Angeles, CA

Hahn-Funk

Los Angeles, CA

Clinical Research Coordinator Hoag Inst for Research & Ed

Assist the Principal Investigator (PI) in the conduct of the clinical study according to FDA and Sponsor regulations and guidelines and ensures the safety and welfare of the research participants
Drafts or reviews template Informed Consent Forms with Clinical Research Office per FDA, ICH, GCP guidelines and Hoag Policy language
Perform other duties as assigned
Schedule or assist in scheduling follow-up visits for enrolled subjects
Documents and reports Unanticipated Problems, Adverse Events and Serious Adverse Events according to Clinical Research Office policy, Sponsor, IRB, FDA, ICH and GCP guidelines and specific protocol, to the Investigator, Sponsor, Clinical Research Office administrative staff, and IRB
Complete the Case Report Forms for the study accurately and completely. Abstract data from hospital record and physician charts to complete CRFs
Accommodates changes in workload within the department and demonstrates flexibility in accepting work assignments. Performs assignments as directed by Supervisor

present

Philadelphia, PA

Oncology Clinical Research Coordinator Days CHI Health Cumc Bergan Mercy

Philadelphia, PA

Kuphal, Keeling and Pacocha

present

Philadelphia, PA

Oncology Clinical Research Coordinator Days CHI Health Cumc Bergan Mercy

present

Participates in all mandatory quality improvement, safety, security, and infection control program
Collects, manages and maintains patient and laboratory data for clinical research studies
Serves as subject matter expert for all phases of the research trials as assigned
Enters patient information into clinical research database and maintains patient information in research database to ensure proper research accounting
Analyzes and abstracts data from departmental and medical record charts to complete and submit case report forms
Exhibits thorough knowledge of database application programs
Assists, updates and communicates with members of the disease portfolio team by providing knowledge of assigned protocols. Ensures timely and accurate reporting of all Adverse Events

Education Education

Bachelor’s Degree in Sciences

Oregon State University

Bachelor’s Degree in Sciences

Skills Skills

Partner with members of the Operations and Research teams to play an active role in ensuring the success of Company-led research studies
Lead the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
Monitor performance of investigational sites
Educate study sites in correct collection, processing and shipping of biospecimens to central repository
Act as the voice of the Company with study participants and other external partners
Interact with potential study participants, educating them about the study including the possible risks/benefits, procedural details and significance of the study; answers study related questions posed via e-mail or phone calls from potential participants and/or the general public
Data collection and data entry, including performing regular audits to ensure that the data collected is complete and accurate
Assist with the production of participant education material, research newsletters, development of web content and online project communication
Communicate progress and research findings with regular presentations
Handle various administrative activities generally associated with conducting research studies

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Clinical / Translational Research Coordinator Resume Examples & Samples

Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations
Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
Understanding and capability to accurately and compliantly perform the procedures required of each study protocol, working collaboratively with study participants, other staff and departments, in safely and accurately performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage, etc. Ability to identify and troubleshoot problems
Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation
Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures
Knowledgeable of the safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies
Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work
Engages in a minimum of 10 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification
Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor
Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel
Furthers knowledge by completing more advanced job-related educations (such as Research Support Services Boot camp Follow-up). Actively seeks new learning opportunities, seeing learning as a part of work. Develops and achieves personal and professional goals

Clinical Trials Research Coordinator Resume Examples & Samples

ComplianceSupport & comply w/ the Principles of Responsibility (Kaiser Permanente Code of Conduct). W/ guidance from PI, assist w/ ensuring compliance w/ KPNC IRB Standard Operating Procedures (SOP) & document applications. Adhere to Guideline for Good Clinical Practice (GCP), federal, state, & local regulations, & KP policies & procedures. W/ supervision, assist w/ preparation for inspections, audits & monitoring visits
Assist w/ obtaining medical records & test results for all projects/participants. w/ supervision & certification, perform packaging & shipping of protocol specimens to the Sponsor lab in accordance w/ IATA/DOT regulations & Sponsor shipping guidelines. Direct issues requiring medical decision-making to the appropriate licensed staff member promptly
This job description is not all encompassing

Clinical Trial Research Coordinator Resume Examples & Samples

Study Implementation: Maintain the security & confidentiality of participants' paper or electronic data (e.g., case report forms kept in a secure, locked space). Assist w/ scheduling participants for study assessments/visits, required tests including visit-specific laboratory kits and/or paperwork preparation. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.)
Under specific direction, assist w/ data entry of study activity onto a case report form (paper or electronic), & maintain a database program to track all study activity (i.e., study enrollment & consents). Assist in maintaining research charts & site regulatory files. Assist in ensuring that study-related, non-test article supplies are shipped & re-supplied according to protocol, including tracking expiration dates. Assist in obtaining protocol specific regulatory documents including MDs/RNs licenses & CVs
Report any potential protocol violations/deviations to the PI in a timely manner. Support the regulatory team in the maintenance & storage of critical documents required to be maintained & provided to the Sponsor during the conduct of the trial. W/ supervision, assist in study closure activities including preparation & collection of close-out documentation, & preparation of study files for distribution to longterm storage
Clinical trials experience preferred
Primary responsibilities are to provide data management in a timely manner for patients on cancer trials including facilitating patient entry into programs and managing and collecting data for submission to research centers. Will manage all screening, active treatment and follow up data form submissions, xrays, and pathology specimens for all protocols patients. Will assist in the oncologists’ in ordering/scheduling specific protocol tests/appointments as directed. Will require travel by own reliable transportation to different centers to assist in patient enrollment and adherence to all research requirements. Maintain IRB regulatory material at the local site level. Coordinate adverse event/serious adverse event submissions to the IRB and sponsors. Prepare and assist in any required audits. Assist the Director and Manager of the Program in other assigned projects. Willing to abide by Good Clinical Practice Guidelines and all FDA regulations. CPR-certified required

Clinical / Tran Research Coordinator Resume Examples & Samples

Approximately 60% of time will be spent administering, scoring & entering standardized tests for various studies in the lab
Assist in the recruitment and screening of 900 students in the Nashville area
Maintain participant files (scanning consents, teacher paperwork, REDCap uploading of docs, move-to-server, etc.)
Assist in preparation of training materials for grants
Assist in auditing graduate research assistants’ test administration and scoring as needed
Assist in the preparation of materials for publication
Assist in general lab procedures as needed
Assist in planning for high-volume participant seasons, including preparation of materials, logistical planning, scheduling, & other duties as needed
Provide support as needed during high-volume participant seasons

Clinical Trials Research Coordinator Resume Examples & Samples

Study Implementation Maintain the security & confidentiality of participants' paper or electronic data (e.g., case report forms kept in a secure, locked space). Direct issues requiring medical decision-making to the appropriate licensed staff member promptly. According to protocol &/or IRB-approved telephone script, collect & document research data & report the information to the appropriate licensed staff member & PI for assessment in a timely manner. Coordinate & schedule participants for study assessments/visits, required tests, including visit specific lab kits &/or paperwork preparation, etc. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.). W/appropriate guidance, obtain & review medical records & test results of all project/study participants & abstract needed data per protocol requirements. W/guidance from PI, complete case report forms (paper or electronic) & maintain a database program to track all study activity including study enrollment & consents. Respond to Sponsor to resolve data queries & delinquencies in a timely manner. Report any potential protocol violations/deviations to the PI in a timely manner. Assist in the collection of protocol required data w/ timely & accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions). Coordinate & prepare protocol specimens for shipping or storage in accordance w/ IATA/DOT regulations & Sponsor shipping guidelines. Assist w/ participant's long-term follow-up data collection. Assist PI &/or Clinical Trial Nurse, if applicable, w/ identifying, screening, & recruiting potential participants. Provide PI &/or Clinical Trial Nurse w/ the ongoing informed consent process by coordinating the current consent documents. Assist in study closure activities including preparation & collection of close-out documentation, & preparation of study files for distribution to longterm storage. W/guidance, receive, disseminate & maintain study-related communications w/ internal & external parties involved w/clinical trial protocols
One (1) year of experience in clinical trials research OR a bachelor's degree required
Current ACRP or SoCRA certification preferred

Research Coordinator Clinical Research Resume Examples & Samples

Bachelor Degree or equivalent experience
Patient care experience
Clinical Research experience
Regulatory guidelines regarding research (example: ICH-GCP and FDA regulations.)
Basic computer knowledge; must be able to perform cashier duties
Medical and nursing equipment and supplies
ECG machine
Oncology related experience

Clinical Research Coordinator Pulmonary Critical Care Resume Examples & Samples

Bachelor of Science or related degree
Master’s in Public Health or related clinical field
Experience in area of assigned clinical specialty

Clinical Trials Research Coordinator Resume Examples & Samples

Theoretical knowledge of a biological science such as Biology, Microbiology or a related field. Demonstrated knowledge of research methods
Demonstrated experience conducting clinical trials. Proven experience in research protocol start up procedures, marketing, outreach, recruitment, and screening of research subjects
Demonstrated experience with the management and design of protocols, data gathering, and evaluation
Demonstrated experience taking patient history, evaluating patient problems and providing accurate and complete documentation in patient record
Demonstrated experience collecting, evaluating, and interpreting routine standard lab tests on human subjects, i.e. blood tests, vital signs. Ability to read and interpret lab results and summarize scientific data
Organizational skills with the ability to prioritize workload effectively and efficiently to meet firm deadlines in an environment with multiple interruptions and changing priorities while exercising independent judgement, showing initiative and resourcefulness when making decisions
Strong interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills
Computer proficiency, including word processing, spreadsheet software and internet browser applications. Thorough database management skills
Experience with cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures
Experience in data analysis and presentation
Knowledge of and ability to operate various industry programs and vendor software
Experience reading and interpreting EKGs
Experience working in a cardiology department/setting

VAD Clinical Research Coordinator Resume Examples & Samples

Outline your service excellence, communications and event planning skills and experiences which would be applicable to this position
Describe your key impressions of the FCVC presentation found here
Assist with the recruitment and retention of subjects, scheduling of procedures, and collection of data. Track visits ensuring compliance with protocol requirements

Clinical Research Coordinator Ii Neurology Days Msh Resume Examples & Samples

Coordinates the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects
Obtains informed consent under supervision of the Principal Investigator, Clinical Research Manager, or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for studies involving genetic tests
Knowledge of standard concepts, practices and procedures in directly related field

Clinical Research Coordinator Cardiology Resume Examples & Samples

Conducts routine and standardized human subjects research using appropriate research or interview techniques specific to subject matter of the research project, providing support to the Principal Investigator
Assists in the activities related to clinical research including, but not limited to: obtaining informed consent, screening participants for eligibility, registering patients with sponsoring agencies, administering questionnaires and answering telephone calls
May assist in the preparation for regulatory agency site visits

VAD Clinical Research Coordinator Resume Examples & Samples

Describe your key impressions of the FCVC presentation found here: www.med.umich.edu/cv...cvcpotentialteam.pdf
Maintains accurate research records and transcribes collected data onto source documents and electronic case report forms. Upload images, request records, and file documents appropriately for audit readiness
Assist with identification, documentation and reporting of adverse events according to standard operating procedures and protocol requirements
Assists with writing, editing, and renewing Institutional Review Board applications; maintain version trackers for IRB applications, informed consent documents, protocol version trackers, and other related items
Assist with budget and billing calendar development and revisions. Review account statements comparing against payment schedule and billing calendar to ensure accuracy. Prepare and submit requests for billing adjustments and invoices as needed. Maintain revenue tracker and assist with budget forecasting
Assures compliance with protocols, adherence to good clinical practice guidelines, FDA regulations, and all other federal, local, and University guidelines
Perform study-specific tests in clinic such as mini-mental, grip test, and walk test
Other duties as assigned or required for the research project
Some weekend coverage hours are anticipated during study enrollment period
Some overnight travel expected for study related meetings and conferences

Clinical Research Coordinator, CRC Resume Examples & Samples

Partner with members of the Operations and Research teams to play an active role in ensuring the success of Company-led research studies
Lead the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
Monitor performance of investigational sites
Educate study sites in correct collection, processing and shipping of biospecimens to central repository
Closely monitor study subjects' progress, document research observations, and assess the need for action and/or consultation with the Manager of Clinical Research Operations
Act as the voice of the Company with study participants and other external partners
Interact with potential study participants, educating them about the study including the possible risks/benefits, procedural details and significance of the study; answers study related questions posed via e-mail or phone calls from potential participants and/or the general public
Data collection and data entry, including performing regular audits to ensure that the data collected is complete and accurate
Assist with the production of participant education material, research newsletters, development of web content and online project communication
Communicate progress and research findings with regular presentations
Handle various administrative activities generally associated with conducting research studies
Bachelor’s Degree in business administration, health care administration or related field
Minimum of two years of experience in clinical research
Experience working on a research study with a biobank component strongly preferred
Passionate about Clinical Studies
Strong organizational, and communication skills
Energetic and self-motivated
“Think outside of the box” mentality
Driven to meet ongoing research milestones
Strong problem-solving skills and willingness to go the extra mile to get the job done
Ability to efficiently acquire new technical skills or domain expertise
Positive attitude and is open to close collaboration within a dynamic and driven team

Per Diem Clinical Research Coordinator Resume Examples & Samples

Conducts routine and standardized human subjects research using appropriate research or interview techniques specific to subject matter of the research project, under direct supervision of the Principal Investigator or senior clinical research staff
Assesses research subjects including obtaining blood samples through venipunture/finger stick, measuring blood pressure, counseling subjects based on assessment findings
Read source documents and enter data in specific data fields accurately
Collect, compile, sort and verify the data’s accuracy or completeness before it is entered
May perform data integrity tasks by locating and correcting data entry errors, or reporting them to supervisors
Bachelor’s in Science or closely related field or equivalent experience
Health care background is a plus

Clinical Research Coordinator, RN Resume Examples & Samples

Reports all serious adverse events to sponsor and IRB of record according to established timelines
Coordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams
Performs and/or oversees a variety of clinical duties that may include but not limited to: EKGs, processing/shipping of blood serum, urine and communicates results to PI and/or APN
Act as principal investigator's representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnel
Maintains accurate, complete, up-to-date records on each patient participating in a clinical trial protocol
Ensures study patient's clinical trial related activities are billed appropriately and reconciles drug study account records with research finance personnel
Prepares and assists for sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit
Develops case report forms and/or databases for physician initiated studies as needed
Assists the principal investigator in preparing for publication. Works with analysts and assists with queries related to data to evaluate the significance of collected data
Provides education to all departments and clinical areas where study is performed
Attends research meetings and conferences as required
Participates in staff meetings and in-service education of nursing and medical staff
Adheres to the standards identified in the Medical Center's Organizational Competencies
Graduate of a NLN/AACN accredited program in nursing
3-5 years clinical nursing experience
Adheres to the American Nurses Association standards
Mandatory education on human subjects research
FDA regulatory, IND reporting, Microsoft or similar Office Suite, oncology or clinical research
NJ State Professional Registered Nurse License

Clinical Trials Research Coordinator Resume Examples & Samples

Theoretical knowledge of a biological science such as Biology, Microbiology or a related field. Knowledge of the basic science of Gulf War Illness, including familiarity with general medical problems and terminology
Excellent organizational skills. Experience planning, organizing, and managing the scheduling of study visits, sponsor visits or teleconferences, and meetings with key personnel, all in the midst of handling multiple priorities and deadlines
Excellent communication skills. Ability to quickly comprehend written and oral instructions. Ability to write legibly to complete data collection forms. Ability to work effectively as a team member
Knowledge and skill in using Microsoft applications including Word, Excel, PowerPoint, and Outlook, as well as research databases, electronic case report forms, and other computer based programs. Ability to organize and concurrently manage information in several formats: paper, electronic, and oral
Experience developing complex surveys that require skip and other forms of logic while utilizing survey-based software
Experience with Qualtrics
Experience coordinating clinical trials in a diseased population with multiple health problems. Ability to read scientific text for general understanding of basic concepts. Ability to summarize and convey technical and medical information to lay individuals at a level appropriate for their understanding
Knowledge of common laboratory tests performed and associated normal results
Familiarity with regulatory documents needed for the conduct of clinical trials. Experience in submitting applications, consents and correspondence to the IRB and/or UCSD Human Research Protections Program for review and approval
Knowledge in the processing and shipping of blood and urine laboratory specimens, both ambient and frozen. Familiarity with guidelines of biohazardous handling. Knowledge and strict utilization of universal precautions when handling laboratory specimens
Familiarity with electronic medical records (Epic preferred) for reviewing hospitalizations, laboratory results, and other clinical data
Familiarity and comfort in communicating with patients with acute and chronic health problems. Ability to advocate for subjects if their understanding of the nature of their study participation is in question

Clinical Trials Research Coordinator Resume Examples & Samples

Study Implementation
Maintain the security & confidentiality of participants' paper or electronic data (e.g., case report forms kept in a secure, locked space). Assist w/ scheduling participants for study assessments/visits, required tests including visit-specific laboratory kits and/or paperwork preparation. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.)
Prefer experience with Excel, Microsoft word, & internet use
Preferred one plus years experience in cancer research and or adult oncology

Temporary Assistant Clinical Research Coordinator Resume Examples & Samples

Schedule and/or call subjects to confirm appointments; contact participants with reminders or other requirements
Prepare, distribute, and process questionnaires
Perform clerical duties in the preparation of regulatory documents. Maintain all forms and documents, including consent forms and master subject logs. File all appropriate correspondence
Prepare, process, and ship specimens/samples accurately under-defined requirements
Order and maintain equipment and supplies
Process study compensation payments and thank you letters to subjects upon completion of trial activities. Assist with post-study activities, as needed
General knowledge of medical terminology
Excellent customer service and interpersonal skills

Clinical Research Coordinator Dept of Surgery Resume Examples & Samples

Assists in the collection, analysis and review of experimental data for publication and presentation
Ensures accurate, confidential and complete compilation of data
May secure and ship clinical specimens as required by the protocol

Clinical Research Coordinator Hal-biltmore Resume Examples & Samples

In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings
Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities
Maintains regulatory documents in accordance with USOR SOP and applicable regulations
Provides a safe environment for patients, families, and clinical staff at all time through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law
HEC

Rn-clinical Research Coordinator Resume Examples & Samples

Maintains investigational drug accountability
Schedules and participates in monitoring and auditing activities
Participates in required training and education programs
May collaborate with Research Site Leader in the study selection process
Additional responsibilities may include working directly with other (non-USOR) research bases and/or sponsors
Minimum one (1) year of experience in a clinical or scientific related discipline, preferably in oncology
Proficiency in MS Programs such as Word, Excel, and Outlook
Good communication
Organized
Independent
Time management

Clinical Research Coordinator Supervisor Resume Examples & Samples

Clinical Trial Professional certification from a professional society must be obtained within one year of position
Demonstrated management and conflict resolution skills to effectively lead and motivate others
Demonstrated experience in training others in the field of research

Clinical Research Coordinator Supervisor Resume Examples & Samples

Clinical Trial Professional certification from a professional society within one year in position
Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research
Ability to perform all commonly applicable functions in word processing and spreadsheet software; effectively use campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems

Research Coordinator, Clinical Trials Office Resume Examples & Samples

Ability to function independently and as part of a team
Excellent communication skills, verbal and written
2 years of clinical experience in a healthcare setting required
Demonstrable computer competency in Microsoft Word and Excel
Certification by the Association of Clinical Research Professionals preferred

Oncology Clinical Research Coordinator Days CHI Health Cumc Bergan Mercy Resume Examples & Samples

Recruits, screens, enrolls and obtains consent from program participants
Promotes use of open and available clinical studies to appropriate health care providers and venues
Conducts and/or coordinates training for program participants
Assures compliance with all relevant IRB and other regulatory agency requirements
Serves as subject matter expert for all phases of the research trials as assigned
Collects, manages and maintains patient and laboratory data for clinical research studies
Analyzes and abstracts data from departmental and medical record charts to complete and submit case report forms
Maintains and tracks computerized database registration of required research subject data, including demographics, clinical, laboratory and tracking data
Verifies research subject eligibility, required tests, therapy, health status, toxicity modifications, etc
Coordinates collection and shipment of required specimens for protocol if applicable
Participates in audits of assigned protocols
Participates in all mandatory quality improvement, safety, security, and infection control program
Sound understanding of the treatment options available to individuals with health conditions related to the area of research the incumbent will support. Knowledge of how to conduct research is preferred
Has command of verbal and written communication skills and is detailed oriented with data management and protocol execution
Proficient in balancing multiple study protocols, risk management procedures, and quality improvement initiatives
Communicates effectively with a variety of departments, physicians and staff
Maintains strict participant confidentiality, adheres to ethical principals in the conduct of research, and able to prioritize research case load
Able to work independently, be organized and manage time effectively

Bruog Clinical Research Coordinator Resume Examples & Samples

Prior experience working on clinical research trials a plus
Knowledge of some medical terminology required; Oncology terminology preferred
Prior knowledge and training with an electronic database system a plus, or proficiency in learning a computerized data system
Ability to work independently and good time management skills
Detail orientation is critical to this job

Certified Clinical Research Coordinator RN Resume Examples & Samples

Protocol Guidelines: With PI and CRC, develop Standard Operating Procedures (SOPs), “Patient Study Calendars”, Orders, and Eligibility Checklists for all new studies. Must be fully knowledgeable of the specifics of the protocol and ensure that written guidelines are in place. For PI-initiated trials, will work with PI to develop Case Report Forms (CRFs) as well
Liaison with Clinical Departments/Units: Act as liaison with Pharmacy to ensure the investigational drugs are available for protocol. Liaison with Laboratory and/or other hospital ancillary departments as needed
Protocol Training (In Servicing): Train hospital/practice personnel in the specifics of the trial
Enrollment of Patients: Identify patients for that meet criteria for protocol. Screen, consent and reconsent patients for study
Monitoring Visits/Audits: Act as protocol representative during visits from monitors or auditors

Clinical Research Coordinator, Ophthalmology Resume Examples & Samples

Coordinate research protocols; arrange necessary appointments and procedures, collect required data, work collaboratively with other departments and institutions, and maintain contact with study participants
Recruit, screen, enroll and obtain consent from study participants
Organize and maintain study documents including data collection forms, informed consent forms, and regulatory documents
Maintain timelines, including tracking deadlines for program components
Provide back-up coverage for refractions and visual acuity measurements in accordance with varying research protocols; maintain required certifications
Enter data into electronic data capture (EDC) systems
Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study team
Perform ancillary testing including vital signs, intraocular pressure measurement, visual field measurement, optical coherence tomography (OCT), color vision testing, and other basic ophthalmic photography; administer surveys
Assist with the preparation of IRB documents and reports
Assist with the collection of patient samples, including blood, urine, and saliva; process and prepare specimens (centrifuge, pipette as required)

Clinical Research Coordinator Clinical Trials Unit Women s Health Resume Examples & Samples

Current Basic Life Support (BLS) certification from the American Heart Association
6 years relevant research experience in a clinical setting or 3 years of research experience in a clinical setting with a Bachelor of Science degree
Experience working independently, organizing work, and setting priorities
Must have computer skills and dexterity required for data entry and retrieval of information

Clinical Research Activation Coordinator Resume Examples & Samples

Manage the processes required for identification, assessment, submission and initiation of clinical research studies at the Massey Cancer Center in collaboration with all members of the research team
Identifies potential clinical trials to fill out protocol menu
Manages and designs systems to identify, evaluate, and usher new clinical trials through the activation phase
Interface with clinical investigators, trial sponsors and others involved in the clinical research process
Develop, establish and maintain productive relationships with VCU colleagues and customers to achieve essential clinical research outcomes
Meets directly with investigators, regulatory, and administrative supervisors and team members

Qualitative Clinical Research Coordinator Resume Examples & Samples

Communicate effectively across interdisciplinary project teams across institutions, to include project updates, pending tasks, and team meetings
Prepare, coordinate and track materials for all initial, modification and continuing review IRB submissions
Review literature and synthesize findings on a variety of child health topics
Develop, maintain, and update data collection instruments (e.g. interview guides, surveys) for research purposes
Assist project team with data collection, management, and analysis
Conduct interviews and focus groups with research study participants
Create and manage NVivo project files among team members
Perform analyses using NVivo query functions and memoing in preparation for team meetings, under direction of lead investigators
Participate in conversations with multidisciplinary team members concerning the research process and future directions to ensure high quality and high impact research
Assist in all aspects of preparation of scientific manuscripts for submission to peer reviewed journals
Apply relevant project lessons and skills to ongoing PolicyLab initiatives
Bachelor's degree with two (2) - five (5) years of public health research experience OR Master's Degree in Public Health or Social Work with one (1) - 3 (3) years of public health research experience
Experience with NVivo or equivalent Qualitative Data Analysis software required
Masters degree in Public Health (or related field) with at least 3 years clinical research experience
Pediatric clinical research and CDE preferred

Clinical Research Coordinator Hoag Inst for Research & Ed Resume Examples & Samples

Assist the Principal Investigator (PI) in the conduct of the clinical study according to FDA and Sponsor regulations and guidelines and ensures the safety and welfare of the research participants
Designs, implements and manages a system for organizing, planning work flow related to all research study activities. Prepares and presents summary of clinical trial activities if needed
Be knowledgeable of study protocols to complete study activities correctly and completely. Design and/or maintain organizational tools to conduct the study accurately and in compliance with Good Clinical Practice. Develops forms, check-lists and other tools to facilitate study completion and compliance
Assist the PI in the active recruitment and screening of potential research participants according to the protocol’s inclusion/exclusion criteria. Schedule research participant’s visits in accordance with 1 study protocol. Assist the PI in the training of other site personnel and other medical staff in understanding and implementing the protocol
Drafts or reviews template Informed Consent Forms with Clinical Research Office per FDA, ICH, GCP guidelines and Hoag Policy language
Discusses research study with potential research participants and answers any questions while coordinating the process of obtaining the research subjects informed consent prior to participation in the study. . The CRC shall seek guidance from the Principal Investigator for any questions he/she cannot accurately answer for the research participant regarding the study or participant’s medical condition
Schedule or assist in scheduling follow-up visits for enrolled subjects
Documents and reports Unanticipated Problems, Adverse Events and Serious Adverse Events according to Clinical Research Office policy, Sponsor, IRB, FDA, ICH and GCP guidelines and specific protocol, to the Investigator, Sponsor, Clinical Research Office administrative staff, and IRB
Complete the Case Report Forms for the study accurately and completely. Abstract data from hospital record and physician charts to complete CRFs
Work with ancillary staff areas (e.g. Operating Nursing Care, Cath Lab, Pharmacy, Pathology, Radiology, Laboratory, Medical Records) within the hospital affected by research activities
Maintain accurate and complete records of the receipt, dispensing, and return of all investigational supplies, including study drug(s) or devices, and report any discrepancies to the PI and Sponsor
Maintain required regulatory and other documentation in the study documentation file. Maintain records of research participants enrolled in the study
Communicate with the study sponsor regarding study activities as necessary. Participates in required study visits such as Initiation Visit, Routine Monitoring Visits, Close-out Visits and audits. Reviews study records and meets with site visit teams/monitors, the FDA, or other inspectors as designated by sponsor when required. Resolves queries generated from Sponsor or other monitoring/auditing reports
Completes study Institutional Review Board submission application and ensures Investigator's review. Communicate with the designated IRB on study approvals/closures, and adverse event reporting
Work with the Clinical Research Office (CRO) administrative staff on all required aspects of study submission, continuing reviews, adverse event reporting, and study closure. Maintains current knowledge of Clinical Research Policies and Procedures
Works with Clinical Research Office administrative staff in developing a detailed cost analysis, study budget preparation, and tracking/distribution of study funds
Accommodates changes in workload within the department and demonstrates flexibility in accepting work assignments. Performs assignments as directed by Supervisor
AA degree
Minimum 1 (one) year of Clinical Research Coordinator experience
Patient coordination experience in complex clinical trial setting required (does not include Regulatory position)
Medical terminology required
Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines. Understanding of clinical trial methodologies and experience filing Institutional Review Board documents

VAD Clinical Research Coordinator Resume Examples & Samples

Describe your key impressions of the FCVC presentation
Certification through ACRP or SOCRA or willingness to become certified
Demonstrated knowledge of medical and research terminology and familiarity in heart disease
Knowledge of preparation of regulatory documents for clinical trials for submission to IRB (eResearch)
Ability to work with minimal supervision with diverse teams of people in a diplomatic, collaborative and effective manner
Excellent interpersonal, oral, and written communication skills with exceptional attention to detail
Exceptional organizational and computer skills are required with proficiency in Microsoft software applications
Demonstrated problem solving and conflict resolution skills
Ability to multi-task, work well under time constraints and meet deadlines
Demonstration of commitment to FCVC Core Values
Previous experience of 1-2 years with coordination and management of device trials (IDE and HDE) desired

OPS Clinical Research Coordinator Resume Examples & Samples

Experience working with ICU patients
Familiarity for medical terminology
Knowledge of basic anatomy

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