CTSRMC Coordinator C

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. Penn has 12 schools providing opportunities for undergraduate, graduate and continuing education, influenced by Penn’s interdisciplinary approach to scholarship and learning. Penn has been named one of America’s Best Large Employers in 2023 by Forbes.

Penn offers a unique working environment in Philadelphia with a diverse range of educational, cultural, and recreational activities. The University offers a competitive benefits package including healthcare and tuition benefits for employees and their families, retirement benefits, professional development opportunities, and wellness resources.

CTSRMC Coordinator C

Coordinator C

The Clinical Trials Scientific Review and Monitoring (CTSRMC) Coordinator C reports to the CTSRMC Manager and is responsible for coordination of the initial, ongoing and annual review of research protocols submitted to the CTSRMC for scientific merit, feasibility, disease relevance, prioritization, competitiveness and statistical design.

Job Responsibilities

• Pre-review submissions assigned to the CTSRMC for completeness and compliance with NCI, federal and institutional regulations/policies.
• Provide expert guidance to investigators and study teams to improve the quality of study documents, including the protocol and informed consent forms (ICF).
• Ensure appropriate AE/SAE language in protocols, compliance of Medical Monitoring/DSMB sections with NIH guidelines, description of study monitoring or auditing, and identification of sponsorship roles and cancer center auditing in institutional protocols.
• Review claims of exemption and expedited submissions to determine appropriate level of review and triage submissions to scientific, statistical or regulatory reviewers as appropriate.
• Perform quality control steps within strict timelines to minimize delays in time-to-activation; ensure only high-quality protocols move forward to scientific peer review.
• Assist the manager with preparing meeting agendas and documents for committee meetings, convert documents and post them to a secure website, attend meetings, and coordinate investigator and member arrival while following a timed agenda.
• Maintain accurate notes on attendance, discussions, actions, votes, and priority scores; review recorded minutes and ensure documentation is complete.
• Communicate verbally and in writing with investigators and study teams regarding CTSRMC actions.
• Maintain meticulous documentation of all CTSRMC-related activities following policies for file management, version control, and naming conventions; real-time tracking in a custom database is essential.
• Participate in training for committee members, study teams and junior staff; contribute to DOCM quality improvement initiatives.
• Interact with Penn’s IRB to harmonize review of cancer-relevant study protocols.

Qualifications

• Bachelor’s degree (BA, BS, or BFA) and 3–5 years of experience or equivalent combination of education and experience. Preference for BA/BS/BFA. Direct experience in clinical research conduct or operations required.
• Experience with IRB and/or scientific review in an academic cancer center is a strong plus.
• Demonstrated project and time management skills; ability to work independently with minimal supervision; strong organizational skills; ability to work in a team; excellent written and verbal communication; proficiency with multiple databases; commitment to customer service and collaboration; ability to work in a fast-paced, deadline-driven environment; strong analytical and critical thinking skills; problem solver; and ability to build trust across the institution.
• Work may require travel between offices and to off-site locations; must have reliable travel means. Some work outside regular hours may be required.

Note: Position is contingent upon continued funding. Relocation and/or visa sponsorship is not available. Fully remote work options are not available; this is a hybrid eligible position with on-site work several…