Clinical Research Coordinator B (Neurosurgery)

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Posted Job Title

Clinical Research Coordinator B (Neurosurgery)

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center. Independently manages different phases of complex clinical trials and mentors coordinators and research assistants. Works with partnering institutions and creates multi-center budgets and manages expenses. Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of multisite trials.

Job Description

Job Responsibilities

• Prepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as apropriate 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.
• 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 concomitan