Clinical Research Coordinator A/B (Department of Rehabilitation Medicine)

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 (Department of Rehabilitation Medicine) Job Profile Title Clinical Research Coordinator A Job Description Summary This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions. Implement approved changes to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects Job Description Job Responsibilities: Clinical Research Coordinator A This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions. Implement approved changes to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects. Qualifications: Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required. This position is contingent upon funding. Working Conditions Office, Library, Computer Room; Requires extensive safety Physical Effort Typically sitting at a desk or table; Occasional lifting 25 lb. or less Job Responsibilities: Clinical Research Coordinator B Prepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as appropriate 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 Ensure proper reporting of serious and non-serious adverse events to the Sp