Soc/Clin Research Specialist | The University of North Carolina at Chapel Hill - Military Veterans

at HERC- Carolinas

Chapel Hill, North Carolina

Vacancy ID: P013554 Position Summary/Description: This position's responsibility is to implement and manage multiple industry and/or federally funded clinical research protocols, as well as Investigator initiated trials under the general supervision of the Clinical Study Manager and respective Principal Investigators (PI's). This position serves multiple investigators in the various areas surrounding Abdominal Transplant patients. These areas may include pre-transplant renal failure, post-transplant conditions and dialysis access trials. Will be asked to interact with a large, multi-disciplinary team and chronically ill patients undergoing surgical procedures. Occasional attendance in the OR setting may be required. The ideal candidate should be able to implement and manage a variety of clinical study coordinator duties to include start-up, regulatory, trial conduct, study subject management, as well as assist in financial management. The Specialist will be assigned a sub-set of trials for which they will serve as the primary coordinator for overall management of regulatory, recruitment, study conduct, and maintenance. The Specialist works with delegated authority from the Principal Investigator to ensure that these clinical trials are conducted in a manner to meet all federal, sponsor, and university requirements. The Specialist acts as a primary contact on the assigned trials for the sponsor, investigators, and subjects. Activities conducted by this position include: recruitment and consenting; training (attending off-site study meetings as required; attending study teleconferences/training; facilitating investigator and trials personnel training); data management (adverse event/outcome monitoring and reporting, performing data abstraction and completion of CRFs –paper or EDC platforms); logistic maintenance (scheduling and completing research clinic follow-up visits and procedures, maintenance of subject research source files, and facilitating study monitor visits); study subject interaction (study protocol visits, conducting subject telephone follow up visits); collecting/processing/shipment of study lab samples; and performing study specific procedures (occasional attendance in the VIR /OR required). The Specialist will also provide back-up coverage and support for the other clinical trials as needed and is expected to cross-cover for other coordinator team members. The Specialist prepares all documents required for IRB initial and continuing review ( IRB application, consent & HIPAA forms) and for protocol amendments/study updates, providing clarifications to IRB contingencies, coordinating revisions with the Principal Investigator and sponsor. The Specialist will prepare and submit regulatory documents as required by the trial sponsor, including financial disclosures, delegation of authority logs, training logs, and CVs/licenses. The Specialist must ensure timely and efficient review and processing of regulatory and IRB submissions in order to limit start up time and ensure seamless overall implementation of clinical trials.   Education and Experience: Bachelor's degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Chapel Hill, North Carolina

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