Duties: The Clinical Research Coordinator will be responsible for the execution of all clinical trial aspects from start to finish, including but not limited to the implementation of clinical protocol requirements for IBD-Immunology Initiative (I3), a prospective clinically annotated biobank, and its related studies. The Clinical Research Coordinator will work closely with other study personnel in the University of Pennsylvania's IBD-Immunology Initiative (I3). Duties related to the I3 and/or related studies will include (but are not limited to) patient enrollment and follow-up; organization and maintenance of IRB documents; coordination of collaborative studies utilizing the biobank; database management; coordination with study personnel; tissue procurement and processing. Other general duties include (but are not limited to): attending study related meetings; preparation of documents needed for initiation, monitoring, and close-out visits with sponsors and/or clinical research organizations; maintenance of appropriate study documentation, case-report forms and study binders; preparation and submission of regulatory documents (including those to the University of Pennsylvania Institutional Review Board); maintenance of telephone and/or email and/or mail follow-up with all study patients as directed by protocol and in a timely manner; assistance with mailings and other clerical duties; screening of potential patients for research studies and collaboration; scheduling appropriate clinical research study patient appointments; processing and shipping blood, stool and/or tissue specimens for clinical trials; resolving regulatory-related queries; performance of blood draws or other measurements and testing. They will participate as part of a multidisciplinary team member.

The Clinical Research Coordinator will also assist with visits with respective academic and industry collaborators as well as interact with internal and external physicians to recruit appropriate patients for ongoing studies. They will review new protocols for appropriateness and feasibility, coordinate designated studies ensuring all records are updated and readily available to the study staff, department, university, sponsor and regulatory organizations upon request.

Qualifications: A Bachelor's Degree and at least 2-4 years of experience or equivalent combination of education and experience required. A coordinator must be detail-oriented, have prior experience with IRB guidelines, policies, human subject research practices and appropriate professional skills in the execution of research protocols. Must have a strong ability to communicate with clinicians, researchers and patients. Job will require communication with staff and patients outside of office hours.

Reference Number: 40-25708

Salary Grade: 026

Employment Type: Exempt

Org: DM-Gastroenterology

Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

Job Family: I-Technical/Professional Research

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