Clinical Research Job Description
Clinical research
provides scientific and clinical guidance to biology, toxicology, clinical trials management, biometrics, global drug safety, regulatory, and project management staff.
Clinical Research Duties & Responsibilities
To write an effective clinical research job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical research job description templates that you can modify and use.
Sample responsibilities for this position include:
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials
Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators
Provide leadership and expertise in identifying and completing research grants
Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group
Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies
Plan, implement and conclude clinical studies in support of project timelines/market release goals with minimal supervision
Contribute to patient recruitment strategies to increase patient randomization into the trial
Develop and maintain training manuals for study sites
Provide consent template language to study sites
Work directly with study participants to determine subject eligibility and obtain consent
Clinical Research Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Research
List any licenses or certifications required by the position: ACRP, BLS, CCRP, CCRA, CITI, NCCC, CDE, ACLS, CPR, SOCRA
Education for Clinical Research
Typically a job would require a certain level of education.
Employers hiring for the clinical research job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Education, Health, Nursing, Medical, Biology, Healthcare, Communication, Associates, Chemistry
Skills for Clinical Research
Desired skills for clinical research include:
Medical terminology
ICH and local regulatory authority regulations regarding drug
Clinical research protocols
Access
Clinical research process
Budget management
Microsoft Office and the ability to learn appropriate software
Biology
Microbiology
Data management program
Desired experience for clinical research includes:
A BS/AAS is preferred in animal science, zoological, biological sciences, veterinary technology specifically related to Laboratory Animal Research required
A minimum of two years’ experience coordinating animal research protocols OR certification as a Research Animal Coordinator (RAC)
Ph.D., M.S., or graduate-level professional degree in a biological, biomedical, chemical, health sciences, or related fields
Knowledge of clinical study design and execution
Compliance with company regulations
Oncology experience (required) Hematology experience (plus)
Clinical Research Examples
1
Clinical Research Job Description
Job Description Example
Our growing company is looking to fill the role of clinical research. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical research
- Screens patients for eligibility for inclusion into the studies
- Oversee care to assure protocol adherence is maintained by staff, serve internally as a resource for nursing (outpatient, inpatient, home care), medical staff and CRO staff
- Provides input into implementation of protocols including setting, systems issues changes to assure that process will work in other areas if needed within NMH
- Participates in development of clinical trials as appropriate
- Collaborates with the principal investigator in all aspects of research study
- Development of study related documents according to study requirements, such as informed consent forms, case report forms, source documents, logs, newsletters
- Follow ICH guidelines on essential document collection needed for clinical trial conduct
- Work with site coordinators, CRO monitors, and cross-functional colleagues to gather and organize documents from clinical team, sites, and vendors in trial master file
- Assist with site file inventorying and QC to ensure study record is complete
- Perform data review of study subjects to ensure data accuracy, completeness, and compliance with clinical protocol
Qualifications for clinical research
- At least ten years in clinical research - preferably oncology research – that includes supervisory responsibility for professional staff
- Possess Associate of Clinical Research Professionals (ACRP) Certification - ACRP Certification Programs
- Possess HIPAA certification – or become certified within 30 days of hire
- Excellent skills in interpersonal communication and organizational skills, the ability to problem-solve and multi-task
- At least 1 year of related experience in clinical research (or Master’s degree and 1 year of same experience)
- Thorough knowledge of monitoring procedures
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Clinical Research Job Description
Job Description Example
Our innovative and growing company is looking for a clinical research. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical research
- Perform reconciliation of lab samples, PDs, and other study data
- Work with cross-functional team to resolve issues
- Screens study subjects for eligibility for inclusion into the studies
- Performs needed procedures for protocol defined research/clinic visits
- Collect, review, track, and ensure appropriate completion of site-specific study/essential documents
- Maintains awareness of overall development in the field of clinical research based on current literature, attendance at professional meetings, continuing education
- Regulatory Coordination, prepare initial regulatory documents and update them as needed
- Coordinator and communication, Schedule and coordinate site evaluation visits
- Data Management, Review incoming subject SAE information and assist in submission of SAE and compose SAE reports
- Supervise and provide oversight and guidance as needed to research staff
Qualifications for clinical research
- CRA certification preferred
- The CRM is the country point of contact (POC) for assigned protocols between ROC and
- Bachelor’s Degree in Nursing or related field and 3 years of experience in the field of clinical research
- 2+ years independently monitoring cardiovascular/vascular trials
- Prior experience working on device trials preferred
- Experience of CTMS preferred
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Clinical Research Job Description
Job Description Example
Our growing company is looking to fill the role of clinical research. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical research
- Be the POC for assigned protocols between ROC and CO
- Be responsible for quality and compliance in assigned protocols in country
- Be responsible for collaboration with functional outsourcing vendors, investigators, other external partners
- Collaborate internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries
- Collaborate with research nurses, physicians, and other caregivers to identify appropriate study candidates
- Prepare and submit study specific regulatory documents to IRB prepare and submit annual, quarterly, and other intermittent reviews to IRB
- Coordinate implementation of protocol treatment and follow-up
- Coordinate tumor and other specimen collection and submission specific to study adhering to applicable shipping federal guidelines
- Evaluate protocol study forms for completeness, accuracy and compliance to protocol
- Assist research team with administrative support as required
Qualifications for clinical research
- At least 2 years of experience working as a CRA or equivalent preferred
- Be driven to meet commitments and deliver high quality work on time
- Perform assigned tasks independently, prioritize tasks with help from manager and study leads, and escalate issues as necessary
- Demonstrate initiative in all aspects
- Work closely with other members of the clinical operations team and proactively offer support wherever needed
- Collaborate with cross-functional teams, adapt to changing timelines with composure, and exhibit enthusiasm to supply on-time deliverables
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Clinical Research Job Description
Job Description Example
Our company is searching for experienced candidates for the position of clinical research. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical research
- Collaborate with Research Compliance Coordinator on research billing
- Assure ongoing compliance with all IRB and department policies for regulatory documentation of research processes
- Possess a working knowledge of disease state and investigation product
- Manages a Practices clinical research program and operations in accordance with USON SOP and ICH GCP guidelines
- Develops and implements short term goals that align with the companys vision and business goals
- Responsible for the recruitment, interviewing, recommending hires, assessing performance, recommending salary changes, progressive discipline, and retention of staff
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan
- Assists Principal Investigator to assure that all key personnel or persons 'engaged' in the research project have met training requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures
- Cooperates with compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office
- Cooperates with sponsoring company compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office
Qualifications for clinical research
- Must have experience as a Clinical Research/Clinical Trial Manager
- Must have experience managing others
- Experience auditing and coordinating audits of systems and practices to ensure quality and regulatory compliance
- Ability to assist with achieving financial and operations targets for assigned research areas through participation in program planning, budget development, and development of operational practices
- Minimum of 5 years’ experience in the pharmaceutical industry, at a CRO or hospital including clinical research experience
- Strong knowledge on drug development, clinical research operations and regulatory requirements including GXP, ICH and local regulations or FDA CFRs (if applicable)
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Clinical Research Job Description
Job Description Example
Our company is growing rapidly and is looking for a clinical research. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical research
- Administer and conduct the daily operation of the clinical investigation including scheduling
- Supply and equipment needs, maintenance and oversight
- Assist the Principal Investigator in answering the research questions by executing the routine functions of the research study/studies and administrative oversight of the project(s) to ensure that it is executed successfully
- Provide coordination of investigators with study site personnel
- Create Standard Operating Procedures (SOPs) for and maintain oversight and responsibility for all study data collection processes as outlined in IRB approved protocols, including archiving and file management
- Complete initial set up and close-out of study/studies files and databases, collection and data entry, and on- going organization and maintenance of all research study/studies records and data in a computerized format
- Assist the principle investigators with assorted administrative tasks as needed
- Responsible for all study approval submissions and processes
- Responsible for explaining research protocols and obtaining signed consent from patients and research trial candidates as required per protocol
- Assist investigators as needed with construction and maintenance of study databases and study data collection forms, and data entry tasks
Qualifications for clinical research
- Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Czech Republic
- Fluency in both English and Czech
- Join a stable team of CRAs across Czech Repulic and benefit from outstanding training and development, both initially and throughout your career
- 7-10 years of experience in life sciences or medically related field, including at least 6 years of relevant clinical development experience (e.g., in clinical research, study management, ) in Biopharmaceutical Industry
- Knowledge of global clinical trial design and therapeutic development process, and working knowledge of basic statistics and translational approaches
- Thorough experience in all phases of clinical development process with ideal focus of early drug development