Clinical Research Coordinator A/B

Job Description Summary

This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions.

Job Responsibilities

CRC-B

• Coordinate and conduct clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry
• Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines
• Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations.
• Oversee study preparation and blood sample processing and analysis
• Database management and analysis
• Ordering and stocking supplies, maintaining equipment
• Educate patients and family members
• Promote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection
• Other duties and responsibilities as assigned

CRC-A

• Prepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as appropriate including initial submissions, amendments, continuing reviews, adverse events and serious adverse events
• Coordinate, organize and maintain all documentation required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders)
• Assist in the coordination of Phase I-IV clinical trials
• Participate in the conduct of study audits by sponsors, CRO's, the FDA and other entities as required.
• Schedule patient visits and any necessary testing.
• Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
• Process and ship blood, urine and tissue as required per trial
• Conduct initiation, monitoring and closeout visits with sponsors and/or CROs
• Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation
• Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies
• Coordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as applicable), monitoring subjects for post-administration adverse events or reactions
• Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures
• Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures (e.g., determination of causality for adverse events, deviation/exception requests)
• Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events
• Ensure preparation of study related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start up
• Ensure preparation of all required study related documents for submission to all applicable PENN institutional committees for review and approval to start trial (e.g., IRB, CTSRMC)
• Assist with protocol development to ensure logistical feasibility of all study related procedures and study work-flow
• Other duties and responsibilities as assigned.