Position Summary

The Cardiovascular Clinical Research Unit (CCRU) Team seeks a full-time Clinical Research Coordinator to assist in the organization, coordination and implementation of clinical research studies involving a wide variety of investigational products and various sponsors. This position will report directly to the Associate Director, Clinical Research Operations and work directly with PIs on clinical research performed. He/she will be responsible for supporting the following 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 CCRU. We are looking for an enthusiastic, professional and committed team member to work closely with our clinical research investigators, research managers and regulatory personnel. 

Career Development Opportunities 

The CCRU is focused on career development of CRCs and offers an advanced infrastructure of leadership and training to guide and support new CRCs from initial training, to continued professional growth.

Position Responsibilities

This individual will work under general supervision 

The CRC will assist in the coordination of complex 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. The CRC is also responsible for research lab specimen processing/handling. The CRC will demonstrate vigilance in patient safety, protocol compliance, and data quality, and will participate in data organization for research publications, with potential for co-authorship. Additional details of these responsibilities are provided below: 

• Coordinate the conduct of Phase I-IV investigator initiated and sponsored clinical research studies.
• Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens. Coordinate completion and appropriate documentation of new study staff training during any staffing transitions or for coverage purposes.
• Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits. Interface with regulatory authorities, Sponsors and cooperative groups as directed by the CCRU program managers and associate directors.
• May participate in the clinic to explain a trial and conduct informed consent with the patient and family.
• Schedule and oversee participant visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (GCP) (e.g. scheduling participant visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities).
• Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality.
• Communicate clinical trial patient activity to the investigational drug pharmacy (IDS) to ensure adequate drug supply. Ensure drug accountability and appropriate investigational agent diary completion.
• Participate in the maintenance of electronic study specific case report forms (i.e. REDCap, CRMS etc.) and source document tools. 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 Research Management System (CRMS) in real-time. Maintain clinical trial databases by completing case report forms typically 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. Responsible for IND/IDE reporting and/or assisting Sponsor with annual IND/IDE reporting.

Email [email protected] with interest.

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