Clinical Research Coord III
About The Position
This position will function independently in a clinical research setting and will be responsible for the complete coordination of assigned clinical research activities. The incumbent may have supervisory responsibilities and must demonstrate effective problem solving, writing and communication skills. The incumbent will lead clinical trials/clinical research within the Division of Pulmonary, Critical Care & Sleep Medicine and ensure compliance with federal, state and university policies. Essential functions: Clinical Trial Project Management Support the Pulmonary Medicine principal investigator with industry sponsored clinical trials or internally funded clinical research. Screen daily/weekly to enroll patients into clinical trial. Coordinate with Clinical Research Center, inpatient unit or inpatient auxiliaries to schedule patients for study visits. Visit frequently with the study monitor to ensure compliance with industry protocol guidelines. Ensure compliance with Divisional research tracking log. Process patient stipends. Assist the Division Administrator with any internal/external audits. Attend industry sponsored investigator meetings to gather updates on protocol changes, upcoming amendments, etc. Respond to any new industry sponsored solicitations. Regularly review research study billing to ensure compliance. Clinical trial regulatory management Prepare all CRH paperwork needed for study startup approval. Prepare IRB paperwork needed for study startup. Obtain CRH or IRB approval related to amendments, protocol changes, etc. Assist with registration of the study in ClinicalTrial.gov database. Comply with all institutional, federal, state, sponsor and Divisional policies. Retain records/archive documents after study close out Clinical Trials budget Assist the Division Administrator with the industry sponsored budget proposal. Obtain cost of services for all procedures, study visits, etc. related to trial. Work with Division Administrator to ensure financial feasibility of study. This position will perform ad hoc assignments as assigned by the Supervisor
Requirements
- Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Responsibilities
- Clinical Trial Project Management
- Clinical trial regulatory management
- Clinical Trials budget
- Perform ad hoc assignments as assigned by the Supervisor
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Educational Services
Number of Employees
5,001-10,000 employees
