Clinical Research Coordinator A/B (Dept. of Surgery)

Requirements

• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required. (CRC-A)
• Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required. (CRC-B)
• This position is contingent upon grant funding.
• Job Location - City, State
• Philadelphia, Pennsylvania
• Department / School
• Perelman School of Medicine
• Pay Range
• Equal Opportunity Statement
• The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orien

Benefits

Additional Information

University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B (Dept. of Surgery) Job Profile Title Clinical Research Coordinator A Job Description Summary This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center. Independently manages different phases of complex clinical trials and mentors coordinators and research assistants. Works with partnering institutions and creates multi-center budgets and manages expenses. Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of multisite trials. Job Description Job Responsibilities CRC-A 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. Oversee study preparation and blood sample processing and analysis 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 Job Responsibilities CRC - B Prepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as apropriate including initial submissions, amendments, continuing reviews, adverse events and serious adverse events Coordinate, organize and maintain all documentation required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders) Assist in the coordination of Phase I-IV clinical trials Participate in the conduct of study audits by sponsors, CRO's, the FDA and other entities as required. Schedule patient visits and any necessary testing. Adhere to all University of Pennsylvania, ICF, and FDA guidelines. Process and ship blood, urine and tissue as required per trial Conduct initiation, monitoring and closeout visits with sponsors and/or CROs Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation Other duties and responsibilities as assigned

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