Clinical Research Coordinator III - 133230
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About The Position
Under direction of assigned Principal Investigator (PI) and Project Manager (PM), the Senior CRC will independently coordinate and be accountable for the overall administration of clinical research efforts for a variety of advanced research projects and clinical trials. The incumbent will provide leadership to lower level clinical research coordinators and/or other support personnel. The incumbent will be responsible for coordinating and monitoring clinical trials including providing all aspects of protocol oversight, including but not limited to screening for patient eligibility, consent review, data collection and analysis, ensuring protocol compliance, adverse drug/therapy reaction reports, monitoring patient treatment and toxicities, laboratory and specimen collection, processing, submission, and maintenance of accurate and complete clinical research files. Coordinate development of cooperative group affiliation including credentialing, data entry support, and coordination of training. Assist the regulatory department with Human subjects' submissions, renewals, and safety reports. Oversee research protocol writing, start-up procedures, implementation, recruitment, and close out procedures. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards as assigned. Provide direct assistance to the Research Director in reviewing and verifying research account statements, professional fee statements, and invoicing. Coordinate research efforts with the Moores Cancer Center team through close communication and collaboration with the Associate Administrative Director and Administrative Director. Act as a liaison with other departments and community clinics or agencies for the purpose of implementation of studies. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Work closely with federal and state regulatory officials. The incumbent will work with leadership on developing, improving, and implementing study protocols, offering insight at the regulatory, operational, clinical, and technical levels. Incumbent will oversee the conduct of Clinical Trials by ensuring protocol compliance, filing adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Other duties assigned as needed.
