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Posted Job Title

Clinical Research Coordinator A/B

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

The Penn Neurogenetics Therapy Center (PNTC) supports a diverse group of neurogenetics investigators and clinical research professionals, involving work on investigator-initiated clinical research studies and complex industry-sponsored, first-in-human trials of gene therapies for neurological diseases. The PNTC is seeking a highly motivated and detail-oriented Clinical Research Coordinator who will be responsible for the coordination of assigned clinical studies through their entire lifecycle (startup, conduct and closeout).

Job Description

Job Responsibilities

Clinical Research Coordinator A (CRC A): Primary responsibilities include but are not limited to: 1) Reviewing and comprehending assigned protocols, including study procedures and timelines, to ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement; 2) Facilitating the review of new study agreements and contracts; 3) Assisting with the development of study materials including but not limited to, the informed consent document, case report forms (CRFs), study logs; 4) Recruiting and enrolling study participants, coordinating study visits and serving as liaison between the participant, PI, members of the study team and external Sponsor/CRO teams; 5) Collecting study data, completing source documents, and collecting, processing and shipping biological samples; 6) Completing data entry into electronic databases according to source documents and responding to data clarification requests in a timely manner; 7) Contributing to the maintenance of study files, including but not limited to patient binders, investigator site files and trial master file, as required; 8) Leading or contributing to regulatory submissions and stipulation resolution; 9) Coordinating and attending Investigator Meetings, Site Selection visits, routine monitoring visits, and study close out visits; and 10) Working closely with the study PI and PNTC management team to identify problems, implement approved solutions, and monitor results, as applicable. Depending on study assignment, the CRC may complete research activities at the Hospital of the University of Pennsylvania (primary location), Pennsylvania Hospital (PAH) and/or Children’s Hospital of Philadelphia (CHOP).

Clinical Research Coordinator B (CRC B): Clinical Research Coordinator B is expected to perform the duties above more autonomously and with less supervision from…