Research Coordinator Clinical Research Job Description
Research Coordinator Clinical Research Duties & Responsibilities
To write an effective research coordinator clinical research job description, begin by listing detailed duties, responsibilities and expectations. We have included research coordinator clinical research job description templates that you can modify and use.
Sample responsibilities for this position include:
Research Coordinator Clinical Research Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Research Coordinator Clinical Research
List any licenses or certifications required by the position: ACRP, CCRP, BLS, SOCRA, CITI, CCRC, CPR, IATA, HIPAA
Education for Research Coordinator Clinical Research
Typically a job would require a certain level of education.
Employers hiring for the research coordinator clinical research job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Education, Nursing, Communication, Associates, Science, Health, Health Sciences, Human Relations, Healthcare, Medical
Skills for Research Coordinator Clinical Research
Desired skills for research coordinator clinical research include:
Desired experience for research coordinator clinical research includes:
Research Coordinator Clinical Research Examples
Research Coordinator Clinical Research Job Description
- Screen and recruit patients based on protocol criteria
- Explain study protocols, procedures and treatments to patients and families
- Conduct the Informed Consent process in conjunction with study investigators
- Coordinate study activities and patient care with medical staff
- Prepare laboratory specimens for analysis, monitoring tests and procedures, shipping frozen specimen
- Assess and report adverse study events, including the IRB and any research sponsors
- Ensure that all protocols activities are performed by approved research staff and ensure protocol compliance
- Acquire continuing education pertinent to research and their licensed profession
- Maintain Certificate of Insurance from each site and obtain study/site specific waivers when indicated
- Manages conduct of experimental tests and procedures
- Master’s degree in speech-language pathology, early childhood special education or child development
- Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related
- A bachelor's degree in a social or health science + 2 years’ experience
- Bachelor’s degree in a relevant academic/scientific field (Master's degree preferred)
- Must have clinical experience with patient care
- Ability to analyze and interpret scientific data, policy and procedures
Research Coordinator Clinical Research Job Description
- Handle all data and source documentation, adverse experience reporting and maintenance of complete regulatory files
- Assists the in assessing feasibility of clinical trials
- Reviews specific job responsibilities with Principle Investigator (PI) for each protocol
- Manages Case Report forms and other regulatory documentation
- Reports and monitors adverse events
- Screens, enrolls and performs follow-up of study subjects
- Reviews specific job responsibilities with PI for each protocol assigned as a primary responsibility
- Assists in the preparation for Pre-study visits
- Attends Investigator meetings and other relevant sessions
- Participates in site initiation meeting
- Advanced degree in epidemiology, public health, or related field
- Skilled in the use of computerized systems and databases
- Private transportation is required
- 1 or more years’ experience supporting cardiology clinical trials (interventional cardiology & imaging research, electrophysiology, and heart failure)
- Must complete the Collaborative Institutional Training Initiative (CITI) training prior to starting work and must maintain currency at all times
- Must have and maintain a current Basic Life Support (BLS) certification
Research Coordinator Clinical Research Job Description
- Represents the Principal Investigator in departmental audits external audits performed by representatives of the sponsor for each clinical research project
- In collaboration with Clinical Research Administration (CRA), develops a training plan for newly hired Research Assistants (RA) in the department/service
- Assists in budget preparation and negotiation
- Coordinates Phase II thru IV trials from initial sponsor contact for site selection, study preparation and execution to study completion and close-out
- Determines protocol feasibility and some budgetary issues
- Ability to develop processes to facilitate implementation of the research protocol to provide effective and safe medical research to all subjects
- Performs initial and ongoing evaluations of research subjects and implements care directed towards optimal outcomes
- Appropriately and accurately assesses potential subjects for inclusion and exclusion criteria
- Demonstrates knowledge of available studies, screening potential patients for eligibility, guiding physicians and staff in needed timetables for capturing protocol related data points
- Coordinate and sometimes supervise other research personnel
- CITI Human Subjects Training required within 30 days of hire
- Up to and including 1 year of experience in Phase 2 - 4 hospital or medical group based clinical trials
- Pharmaceutical studies experience preferred
- Clinical knowledge of major therapeutic areas
- Experience with PI initiated studies
- Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's in a social or health science + 2 years’ experience
Research Coordinator Clinical Research Job Description
- Participating in the review and writing of protocols to ensure institutional review board approval within University compliance
- Helping assure compliance with all relevant regulatory agencies
- Overseeing study data integrity
- Implementing and maintaining periodic quality control procedures
- Maintaining all regulatory documents
- Preparing research reports
- Participating in any internal and external audits or reviews of study protocols
- Manages and ensures completion of study activities per protocol.Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment and eligibility requirements
- Manages conduct of experimental tests and procedures.Closely monitors and documents patient's adverse events
- In collaboration with the physician, reviews patients for changes in conditions, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings
- BA/BS degree with a major in science or related
- Fluency in spreadsheet software, ability to develop complex spreadsheets independently
- Well-developed organizational and documentation skills
- Demonstrated ability to exercise tact and discretion in sensitive communications with patients and others
- Experience conducting literature searches using various search engines
- BA/BS degree with a major in biology, public health, psychology, sociology, or related field and five years of experience in administrative analysis or operations research
Research Coordinator Clinical Research Job Description
- Responsible for the handling, packaging, and shipping of dangerous goods under supervision and in compliance with State and Federal regulations
- Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of research data management
- Manages and ensures completion of study activities per protocol.Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements
- Manages conduct of experimental tests & procedures.Closely monitors & documents patient's adverse events
- Assists with the recruitment and retention of subjects, scheduling of assessments, and collection of data (biospecimens and clinical outcomes)
- Manages and ensures completion of study activities per protocol.Collaborating with staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements
- Conducts smoking cessation therapy sessions, in-person and by phone, per study protocol
- Conducts psychiatric diagnostic interviews to determine participant eligibility.Assists with other baseline intake procedures including vitals and height/weight, paper and pencil assessments, and obtaining participants’ smoking verification
- Introduces the study medication to participants and provides instruction on use during the pre-quit session
- Monitors/assesses potential study medication side effects for all assigned participants and works with PI and study physician to manage them as necessary
- Proficient in Microsoft Office programs with emphasis on Excel, Access, Word, Publisher
- Experience with databases, Unix or Linux computer environments, using and modifying scripts for data processing
- Knowledge of medical terminology, and/or the ability to apply relevant information to the assessment, interpretation, and processing of medical data
- Knowledge and experience in managing oncology clinical trials, specifically for Phase I studies
- Excellent verbal, written, editing, communication and interpersonal skills
- Demonstrated ability to craft sophisticated written communication pieces regarding sensitive correspondence