Research Assistant at Penn Med Cancer Center (Philadelphia, PA)

May 6, 2022

Job Profile Title
Clinical Research Assistant A

Job Description Summary
The Clinical Research Unit Cellular Therapy and Transplant Research Team at the Abramson Cancer Center of the University of Pennsylvania seeks a full-time Research Assistant to assist with the organizing, coordinating and implementing of studies involving a wide variety of investigational products and various sponsors. He/she will assist with all aspects of clinical trial coordination including: subject recruitment, data entry, sample collection, subject visits and follow-up and regulatory documentation.

Job Description
This individual will work under supervision from the Program Manager and/or a Clinical Research Coordinator C:

  • Assist coordinators with initiating study procedures for new industry-sponsored and investigator-initiated clinical trials. Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits.
  • Assist with coordination of complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials and registries within the Clinical Research Program. Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens.  Conduct screening of patients in electronic medical records and clinic schedules. Be actively involved in  the planning and implementation of patient recruitment into studies.
  • Develop, schedule and oversee subject visits and any necessary sample collection schedules includingspecimen collection for biobanking studies, coordinating sample drop-off at labs across the Health System and other activities according to protocol and in accordance with Good Clinical Practice (“GCP”). Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
  • Participate in the completion of study specific case report forms and source document tools. May include the development and management of REDCAP web sites for internet data capture. Organize and maintain all documentation required by the sponsor or CRO per GCP – includes source documentation, case report forms, and research charts.
  • Collect, review and report timely, valid, accurate study data. Obtain records required to complete case report forms. Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time. Maintain clinical trial databases by completing case report forms within 5 business days of subject visits and resolving data queries within 10 days of issuance. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission.
  • Coordinate and participate in core study team, disease-site group and ongoing protocol training/compliance meetings. Prepare agendas and record minutes for circulation. Provide regular updates to the research team and unit managers. Assist unit managers in meeting project timelines.

Position is contingent upon continued funding.

Qualifications: 
High School diploma and 1-2 years of experience or an equivalent combination of education and experience required. Bachelor’s degree preferred. The successful candidate must have: (1) basic understanding of or familiarity with Phase I-IV industry sponsored clinical trials or investigator-initiated trials; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) initiative and interest in growing and learning about cancer research; (6) ability to work flexible hours.

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Courtesy of Perelman School of Medicine, University of Pennsylvania