Clinical Research Coordinator A

Job Description Summary

The Penn Neurogenetics Therapy Center is seeking a highly motivated and detail-oriented Clinical Research Coordinator A (CRC A) who will be responsible for the coordination of assigned industry-sponsored, federally-funded and/or investigator-initiated clinical studies through their entire lifecycle (startup, conduct and closeout).

Job Description

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 approval 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 clinical data, completing source documents, and collecting, processing and shipping biological samples, 6) Completing electronic case report forms according to source documents and responding to data clarification requests in a timely manner, 7) Establishing and maintaining study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required, 8) Preparing and managing regulatory submissions and inquiries, and 9) Coordinating and attending Investigator Meetings, Site Selection visits, routine monitoring visits, and study close out visits. As applicable, the CRC A will work closely with the study PI and PNTC study team to identify problems, develop solutions, implement approved changes to procedures and monitor results. As applicable, the CRC A will train junior members of the research team. 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).

The position may require communication with patients and staff outside of office hours. Hours are flexible and may include evenings or weekends as necessary.

The CRC A will promote institutional values of patient and visitor satisfaction by demonstrating courtesy and respect for patients and their families, visitors and other employees. The CRC A will demonstrate competence in the assessment, treatment and care of patients, and is expected to exhibit a professional and compassionate demeanor in performance of responsibilities and to be unfailingly responsive to the needs of patients.

The position is contingent on continued funding.

Qualifications

• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
• The CRC A should be highly motivated and detail-oriented, have strong planning, organizational, multi-tasking, and prioritizing capabilities. The CRC A should possess the ability to work independently and also as part of a team. The CRC A should have a strong ability to communicate with clinicians, researchers, sponsors, patients and families. Prior experience with industry-sponsored trials, start-up activities (financial and regulatory), ethics committees, human subject research policies and practices are preferred.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$46,500.00 - $47,313.00 Annual Rate