The Clinical Research Coordinator 2, under the guidance of the Clinical Research Coordinator Supervisor or designee, and each clinical trial’s Principal Investigator, is responsible for assisting with assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice guidelines and ICH guidelines as applicable. Responsibilities include reviewing study protocol, performing quality checks on source documents specific to the study per SOP within a defined timeframe, attending in-house protocol meetings to review study-related procedures, staffing and visit flow, giving subject instructions at check-in and serving as the primary contact for subjects to handle study-specific questions, concerns, or events, providing subjects’ safety orientation upon checking into the Clinic, obtaining and documenting adverse event data on appropriate forms, managing payment to subjects, and handling responsibilities for dorm assignments, t-shirt allocation, answering queries, and laundry schedule. The role requires excellent written and oral communication skills, ability to understand complex instructions, basic computer knowledge for business correspondence and regulatory document preparation, strong interpersonal skills, excellent attention to detail, exceptional organizational skills, ability to meet deadlines with high quality work, and knowledge of clinical research processes including Good Clinical Practices, informed consent process, drug accountability procedures, and IRB submission and reporting. Required qualifications include a Bachelor’s Degree (preferably in Life Sciences or Health) or 1-2 years of clinical research experience; preferred experience is 2 to 5 years of clinical research experience.
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