Job Summary:

The Clinical Research Coordinator will plan, direct, or coordinate clinical research projects, and will evaluate and analyze clinical data.

Supervisory Responsibilities:

• Directs the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives.

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, drug dispensation 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. Oversees 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, and progress reports.
• 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. Communicates with laboratories or investigators regarding laboratory 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 drugs or devices necessary for study completion.
• Solicits industry-sponsored trials through contacts and professional organizations.

Required Skills/Abilities:

• Knowledge of biological and medical terminology.
• Understanding of the principles of administration and management.

Education and Experience:

• Bachelors degree in a life science or related field required. Masters degree preferred.
• Five to 10 years of related experience required.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.