Job Description Summary
Contributes to investigator-initiated, multi-center, and patient-oriented clinical and translational research studies in the field of pharmacogenomics. Assists in the management of clinical trials by coordinating patient screening, enrollment, data collection, and sample handling. Supports IRB submissions and helps prepare manuscripts and presentations. Works closely with the Principal Investigator and study team to address study needs, implement approved changes, and monitor outcomes. Previous…
experience with Redcap is preferred.
Job Description
Clinical Research Coordinator A: Assist in the coordination of investigator initiated clinical trials in the field of pharmacogenomics and precision medicine including recruit, consent and screen patients according to protocol; Schedule patient visits and any necessary testing; Monitor patients per protocol requirements and ensure adherence to protocol requirements; Organize and maintain all documentation required by the Investigator, sponsor or CRO, includes source documentation, case report forms, and research charts; Collect, review and report study data; Complete case report forms and resolve data queries; Process and ship study specimens including blood; Participate in initiation, monitoring, audit and close-out visits; Participate in study team meetings, and ongoing protocol training; Show vigilance in patient safety, protocol compliance and data quality; Adhere to all University of Pennsylvania, FDA and GCP guidelines.
Job Responsibilities
- Screen, recruit and enroll consenting patients using GCP guidelines and conduct compliance monitoring of study participants
- Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs and processing of biological specimens and manage study data and regulatory files per GCP
- Organize and maintain all documentation required by the Investigator, sponsor or CRO, includes source documentation, case report forms, and research charts.
- Collect, review and report study data. Complete case report forms and resolve data queries.
- Participate in initiation, monitoring, audit and close-out visits; Participate in study team meetings, and ongoing protocol training; Show vigilance in patient safety, protocol compliance and data quality
- Other duties and responsibilities as assigned
Qualifications
- Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
- Position requires a highly motivated, articulate individual with excellent oral and written communication skills.
- Position is contingent upon continued funding.
- The candidate should possess the ability to work independently and also as a part of a team.
- Strong planning, organizational and prioritizing capabilities along with problem solving skills desired.
- Previous experience with Redcap is preferred.
