Clinical Research Coordinator B - Division of Epidemiology

Job Description Summary

The Clinical Research Coordinator B manages phases of complex clinical trials under general supervision. The Clinical Research Coordinator B will work closely with other study personnel in the University of Pennsylvania's IBD-Immunology Initiative (I3) study, a prospective clinically annotated biobank, and its related studies, as well as clinical research trials in the IBD Section of the Division of Gastroenterology. Duties related to the I3 and/or related studies will include (but are not limited to) screening of patients; patient consent, enrollment and follow-up; tissue procurement, processing, storage and shipping; data entry; assistance with Institutional Review Board IRB documents; coordination of collaborative studies utilizing the biobank; database management; and coordination with multiple research projects and personnel. Other general duties include (but are not limited to): attending study related meetings; assisting with the preparation of documents needed for initiation, monitoring, and close-out visits with sponsors and/or clinical research organizations; maintenance of appropriate study documentation, case-report forms and study binders; prepares and process all regulatory documents (including those to the University of Pennsylvania Institutional Review Board); maintenance of telephone and/or email and/or mail follow-up with all study patients as directed by protocol and in a timely manner; mailings and other clerical duties; screening of potential patients for research studies and collaboration; scheduling appropriate clinical research study patient appointments; processing and shipping blood, stool and/or tissue specimens for clinical trials; assisting in resolving regulatory-related queries; performance of blood draws or other measurements and testing. The CRC will work closely with the overall research team to accomplish study goals, identify problems and develop solutions.

***Position contingent upon funding***

Job Responsibilities

• Prescreening of patients to assess enrollment criteria
• Coordinate study visits and procedures such as consent, documentation, tissue collection and processing biological specimens
• Maintain research charts and binders
• Organizing and maintaining all documentation
• Communication with study team members
• Perform general administrative duties to support study team
• Data entry and database management for study participants
• Collecting and processing study specimens
• Participate in recurring study team meetings
• Showing vigilance in patient safety, protocol compliance, and data integrity
• Adhering to all University of Pennsylvania and GCP guidelines
• Establish workflows, pathways, and methods to operationalize protocols
• Regularly prepare, draft, and submit regulatory correspondence
• Mentor/train less-experienced research staff in the completion of their duties when needed

Qualifications

Bachelor's Degree and 2 to 3 years of experience or equivalent combination of education and experience required. Effective problem solving abilities, effective communication and writing skills, ability to work independently and collaboratively as a team, and detail oriented. Knowledge of MS Office application skills including word and Excel preferred. Knowledge of RedCap and/or statistical software (STATA, SAS, SPSS, R) is a plus. Regulatory experience preferred. Experience/training with blood draws is a plus. Candidate must be organized and able to prioritize. Candidate must be able to work independently and collaboratively as a team, creatively problem solve and multi-task.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$52,500.00 - $52,661.00 Annual Rate

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