The Clinical Research Coordinator will plan, direct, or coordinate clinical research projects, and will evaluate and analyze clinical data.
Duties/Responsibilities:
- Monitors study activities to ensure compliance with protocols and with relevant local, federal, and state regulatory and institutional polices. Maintains required records of study activity including case report forms, product application records, or regulatory forms. Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
- Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Reviews accuracy of subject enrollment to ensure that informed consent is properly obtained and documented.
- Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
- Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, progress reports, final reports, and assists in drafting peer-reviewed publications.
- Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
- Participates in preparation and management of research budgets and monetary disbursements.
- Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
- Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
- Collaborates with investigators and staff in the preparation, review, editing, and submission of manuscripts and peer-reviewed publications.
- Communicates with laboratories, clinical sites, contract research organizations, and investigators regarding study conduct and findings.
- Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical studies affairs and issues.
- Orders study supplies and coordinates shipment of product necessary for study completion.
- Solicits new study design and clinical projects through contacts and professional organizations.
Required Skills/Abilities:
- Design and execution of clinical trials / studies.
- Knowledge of biological and medical terminology.
- Understanding of the principles of administration and management.
Education and Experience:
- Bachelor’s degree in a life science or related field required. Master’s degree preferred.
- Three to five years of related experience required.