Clinical Research Coordinator A

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.

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Job Description Summary

This position is based in the Penn Frontotemporal Degeneration Center, part of the Department of Neurology of the University of Pennsylvania's Perelman School of Medicine. The purpose of this position is to coordinate early phase clinical trials through the University of Pennsylvania Frontotemporal Degeneration Center.

Job Description

This position involves working with patients who have rare early-onset neurodegenerative diseases and may exhibit difficulties with language, behavior, memory, and movement. The primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all industry sponsored clinical research/trial protocols in the Penn FTD Center, specifically early phase, complex clinical trials. Responsibilities include: Helping to recruit, consent, and enroll participants; Organizing and coordinating research visits; Performing assessments according to the protocol including neuropsychological testing, questionnaires for patients and caregivers, etc.; Performing clinical assessments such as phlebotomy, vitals, ECG, and assisting with lumbar punctures; Scheduling and obtaining MRI imaging; Collection, handling, processing and shipping of biofluids; Data entry; Query management; Maintaining regulatory documents and binders for clinical trials; Assisting with invoicing for clinical trials; Assisting with preparing and submitting IRB documents for clinical trials; Pre-trial and start-up activities such as creation of source documentation and other duties; Independently manages different phases of complex clinical trials and mentors junior coordinators and research assistants. Works closely with CROs, industry sponsors, regulatory agencies, and other stakeholders; Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings; Maintaining University of Pennsylvania, FDA, and GCP standards and guidelines.

The CRC A will function as part of a multidisciplinary team and will report to the FTDC Clinical Research Program Lead/Assistant Director. 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 responsibilities of the CRC A include but are not limited to: Recruit, screen, and enroll potential study subjects as specified per protocols; Coordinate, schedule and conduct study visits; Collect, process and ship study bio specimens; Administer study assessments, collect study data, complete case report forms, enter data into study databases and resolve queries; Demonstrate vigilance in patient safety and assuring compliant trial progress and data integrity; Assist with preparation and submission of modifications and continuing reviews to the IRB, and file approvals; Organize and maintain all visit, regulatory documentation, and other communications; Coordinate and attend study monitoring visits; Assist with study startup and close out activities, as assigned; Communicate effectively with participants, PIs, study team members, Penn partners, Sponsors, Clinical Research Organizations, external vendors; Participate in center, clinical trials team, and study-specific meetings and trainings, as required.

The position may require communication with patients and staff outside of office hours. Hours are flexible to adapt to protocol requirements, and may include evenings or weekends as necessary. 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.
• PREFERRED: The CRC A should be highly motivated and detail-oriented, have strong planning, organizational, multi-tasking, and prioritizing capabilities, and be capable of problem solving issues as they arise, but willing to seek help as appropriate to complete the work accurately and efficiently. The CRC A should have a strong ability to communicate with clinicians, researchers, sponsors, patients and families. The CRC A should possess the ability to work independently and as part of a team. Prior experience with industry-sponsored trials, early phase trials, ethics committees and/or gene and molecular therapies is preferred.