Clinical Research Coordinator B​/C

Overview

The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) advances the science of cancer care, serves patients by improving clinical outcomes, and offers the best available innovative care to trial participants. The ACC CRU consists of 12 Research Teams supporting disease/discipline-specific medical oncology cancer programs within the ACC.

The ACC CRU Cell Therapy & Transplant (CTT) Research Team seeks a full-time Clinical Research Coordinator to organize, coordinate and implement complex cancer studies involving investigational products and various sponsors. The position reports to the CTT Director of Clinical Research Operations and works directly with physician investigators on clinical research performed. Responsibilities include subject recruitment, data entry, subject visits, follow-up and regulatory documentation, with compliance to Penn policies, FDA, GCP and other regulatory standards.

The Clinical Research Coordinator (CRC) is an essential member of the ACC CRU CTT Research Team. We seek an enthusiastic, professional, and committed team member to work closely with clinical research investigators, Research Team Leaders, clinical research nurses, and regulatory coordinators. The ACC has a strong reputation, including a National Cancer Institute (NCI) rating, and is considered one of the top cancer centers in the country.

We seek a CRC to help accelerate momentum through cutting-edge clinical trials.

Career Development Opportunities: The ACC focuses on career development of CRCs and offers leadership and training to guide new CRCs from initial training to continued professional growth.

Clinical Research Coordinator B Responsibilities

This position works under general supervision.

The CRC coordinates complex oncology clinical research protocols, including accurate data collection, monitoring visits, and regulatory documentation. The CRC also handles research lab specimen processing/handling and ensures patient safety, protocol compliance, and data quality. Responsibilities may include data organization for research publications with potential for co-authorship. Details include:

• Coordinate conduct of complex Phase I–IV clinical trials and registries within the ACC CRU CTT Research Team.
• Complete training to function in the role including electronic databases and specimen processing/shipping; coordinate staff training during transitions or coverage.
• Prepare documents for initiation, monitoring, audits, and close-out visits; interface with regulatory authorities, sponsors, and cooperative groups as directed.
• Involve in patient recruitment planning and implementation; may participate in clinic to explain a trial and obtain informed consent.
• Develop and schedule participant visits and testing according to protocol and GCP; monitor adverse events and follow-up with investigators.
• Monitor subjects per protocol and ensure adherence; maintain data quality.
• Coordinate investigational agent supply with IDS and sponsors; ensure product accountability and diary completion.
• Participate in developing electronic case report forms and source documents; maintain sponsor/CRO documentation per GCP.
• Collect and report timely, valid data; update CTMS and maintain CRFs typically within 5 business days; resolve data queries within 10 days; assist with IND reporting as needed.
• Attend sponsor teleconferences and participate in training meetings; provide regular enrollment updates and contribute to efficiency and quality of research.
• May mentor coordinators with less experience.

Qualifications – Clinical Research Coordinator B

• Bachelor’s degree and 2–3 years of experience, or equivalent combination.
• Practical experience coordinating day-to-day activities of multiple research projects; strong verbal and written communication; ability to learn quickly and multi-task; ability to work as part of a team and independently.
• Knowledge or experience in cancer is preferred but not required; ability to work flexible hours; working knowledge of…