"Clinical Research Coordinator B/C (Abramson Cancer Center)"

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 mission of the ACC Clinical Research Unit (CRU) is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants. The ACC CRU is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 12 Research Teams that support disease/discipline specific medical oncology cancer programs within the ACC.

The ACC CRU Airways Research Team seeks a full-time Clinical Research Coordinator to organize, coordinate and implement complex cancer studies involving a wide variety of investigational products and various sponsors. This position will report directly to the Airways Program Manager and work directly with Physician Investigators ('PI') on clinical research performed. He/she will be responsible for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards.

The Clinical Research Coordinator (CRC) is an integral and essential member of the ACC CRU Airways Research Team. We are looking for an enthusiastic, professional, and committed team member to work closely with our clinical research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator. The ACC received an exceptional rating from the National Cancer Institute (NCI) and is considered one of the top 10 cancer centers in the country. We are looking for a CRC that will help accelerate this momentum through the conduct of cutting-edge clinical trials.

Clinical Research Coordinator B Responsibilities

• Coordinate the conduct of complex oncology clinical research protocols, including accurate data collection and overseeing the quality of the clinical trial data and records, scheduling and conducting study initiation and monitoring visits, and participating in ongoing study protocol training.
• Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens.
• Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits.
• Be actively involved in planning and implementation of patient recruitment into studies.
• Develop, schedule and oversee participant visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (GCP).
• Monitor subjects per protocol requirements and ensure adherence to protocol.
• Communicate clinical trial patient activity to the investigational drug pharmacy (IDS) to ensure adequate drug supply.
• Participate in the development/maintenance of electronic study specific case report forms.
• Collect, review and report timely, valid, accurate study data.
• On behalf of the site, participate in weekly or bi-weekly Sponsor teleconferences.
• May act as a mentor to coordinators who have joined the unit with less research experience.

QUALIFICATIONS

Clinical Research Coordinator B: Bachelor's degree and 2-3 years of experience, or equivalent combination of education and experience, are required. The successful candidate must have practical experience coordinating the day-to-day activities of multiple research projects; effective verbal and written communication skills; ability to learn new methods quickly and multi-task; demonstrated ability to work as part of a team as well as independently; knowledge or experience in cancer preferred but not required; ability to work flexible hours; possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.

Clinical Research Coordinator C: Similar duties as B but with additional responsibilities such as working independently, assisting with study design, and mentoring staff.