| The primary purpose of this position is to provide clinical trials assistance to University faculty performing clinical research in the understanding and treatment of diseases in Pulmonary, Critical Care, Allergy, and Sleep Medicine. Duties are determined by protocol-specific requirements and may include any research activity from protocol development through study closeout. This position involves working with pediatric and adult patients.
60% - Identify and follow clinical trial subjects, accurately completing visit procedures and data collection according to the protocol while maintaining the health and safety of research subjects.
â— Understand and interpret clinical protocols, assess study needs, develop plans for successful implementation, conduct and document visits, evaluate progress regularly, and provide input to integrate improvements.
â— Obtain research consent/HIPAA and screen patients for eligibility based on medically complex inclusion and exclusion criteria, seeking investigator input as appropriate. Educate the patient as well as the legally authorized representative or family when applicable throughout the research participation process.
â— Provide protocol-specific assessments as applicable.
â— Develop and maintain accurate source documentation.
â— Document research findings and data according to protocol requirements and timeline.
â— Assist PI to assess, troubleshoot, and report adverse events or problems with data collection or other research processes.
â— 30% - Provide study-specific coordination of study setup, participant recruitment and retention, development and implementation of data management systems, and reporting responsibilities.
â— Initiate and participate in project update meetings
â— Provide assistance in defining and working through study logistics and feasibility
â— Serve as member of study team who will train others on new study or amendments.
â— Collaborate with other disciplines involved in the research process. Demonstrate effective and efficient communication with study sponsors, monitors, study/department staff, and health team members
â— Provide ongoing quality control audits and implement improvements as needed
â— Position may include infrequent travel (2-3 times/year) for study meetings or training
â— 10% - In conjunction with the departmental regulatory specialist, ensure adherence to research protocols, Good Clinical Practices (GCP), IRB, FDA and other applicable federal, state or local regulations. Assist in the timely preparation and maintenance of compliance and regulatory documents from the initial submission through study closure.
â— Assist with development of clinical research protocol documentation
â— Report findings and adverse events as applicable |
