The Clinical Research Coordinator B/C will assist in the coordination and management of multiple clinical trials along with other research projects and responsibilities in the Infectious Diseases C-STAR Research Team and MOTION Laboratory Group. Duties include screening, recruiting, consenting and enrolling eligible subjects per protocol using GCP guidelines; scheduling clinical and research visits; interacting with clinicians and staff to schedule and oversee research testing; assisting or coordinating specimen collection and transport/shipment of specimen samples; preparing trials for audits and inspections. The CRC will participate in study team meetings and ongoing protocol training/compliance meetings and adhere to all University of Pennsylvania, FDA, and GCP guidelines. The CRC-B/C is responsible for accurate data collection, overseeing the quality of clinical trial data and records, scheduling and conducting study initiation and monitoring visits, and participating in ongoing study protocol training. The CRC B/C also handles research lab specimen processing/handling, demonstrates vigilance in patient safety, protocol compliance, and data quality, and participates in data organization for research publications with potential for co-authorship. Study enrollment/activities may require occasional driving/traveling to other sites offsite from University of Pennsylvania’s Main Campus. Flexibility to work occasional nights/weekends is required. The CRC-C role includes running projects independently, acting in a lead capacity or as back-up to the supervisor, and drafting complex documents including protocols and Manual of Procedure (MOP). Responsibilities include coordinating and conducting clinical trials, promoting good clinical practice, knowledge of federal regulations, acting in lead capacity for clinical trials and projects, assuring compliance with protocols and regulatory requirements, interfacing with regulatory authorities and sponsors, coordinating subject recruitment and informed consent, monitoring subjects per protocol, orientation/mentoring of new staff, scheduling and overseeing subject visits and testing, database management and analysis, participating in weekly meetings, and other duties such as inventorying supplies and maintaining equipment. Qualifications include prior experience with epidemiological studies in infectious diseases, a Bachelor's degree with 2-3 years related experience for CRC-B or 4-6 years for CRC-C, practical experience coordinating multiple research protocols, effective communication skills, ability to learn quickly and multitask, teamwork and independent work ability, knowledge or experience in clinical trials preferred, ability to work flexible hours, and knowledge of Title 21 CFR, ICH, and GCP guidelines. Position contingent upon continued funding.
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