Clinical Research Coordinator A (Affective… at University of… · 3535…

Summary: The University of Pennsylvania, a leading institution in education and research, is seeking a Clinical Research Coordinator A for its Affective Disorders Program. This role involves managing and collecting data for clinical trials, coordinating patient enrollment, and ensuring compliance with regulatory requirements. Responsibilities: - Coordinate and conduct clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry - Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines - Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations - Be primarily responsible for traveling to participants' homes in the evening to set up equipment for sleep studies, and return in the morning to pick up equipment. Must have a personal vehicle for this purpose. Mileage will be reimbursed - Database management and analysis - Ordering and stocking supplies, maintaining equipment - Educate patients and family members - Promote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection - Other duties and responsibilities as assigned Required Qualifications: - Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required Required Skills: Clinical trial coordination, Patient recruitment, Informed consent process, Data collection and entry, Institutional Review Board (IRB) submissions, FDA regulatory compliance, Biological sample handling, Database management, Clinical data analysis, Clinical Practice (GCP) knowledge, Human subject protection Benefits: Health, Life, and Flexible Spending Accounts, Tuition, Retirement, Time Away from Work, Long-Term Care Insurance, Wellness and Work-life Resources, Professional and Personal Development, University Resources, Discounts and Special Services, Flexible Work Hours, Penn Home Ownership Services, Adoption Assistance