Clinical Research Coordinator III -Division of Pulmonary, Critical Care & Sleep Medicine
About The Position
Clinical Trial Project Management Support the principal investigator with industry-sponsored clinical trials or internally funded clinical research. Screen daily/weekly to enroll patients into clinical trials. Coordinate with the Clinical Research Center, inpatient unit, or inpatient auxiliaries to schedule patients for study visits. Visit the study and monitor regularly to ensure compliance with industry protocols. Ensure compliance with the 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, and related items. Respond to any new industry-sponsored solicitations. Regularly review research study billing to ensure compliance. Clinical trial regulatory management Prepare all RAC paperwork needed for study startup approval. Prepare IRB paperwork needed for study startup. Obtain RAC or IRB approval for amendments, protocol changes, and related activities. 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 the cost of services for all procedures, study visits, etc., related to the trial. Work with the Division Administrator to assess the study's financial feasibility. 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.
Nice To Haves
- Master's degree and five years of relevant Pulmonary clinical trial experience.
- Prefer experience and/or certification in Spirometry.
Responsibilities
- Support the principal investigator with industry-sponsored clinical trials or internally funded clinical research.
- Screen daily/weekly to enroll patients into clinical trials.
- Coordinate with the Clinical Research Center, inpatient unit, or inpatient auxiliaries to schedule patients for study visits.
- Visit the study and monitor regularly to ensure compliance with industry protocols.
- Ensure compliance with the 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, and related items.
- Respond to any new industry-sponsored solicitations.
- Regularly review research study billing to ensure compliance.
- Prepare all RAC paperwork needed for study startup approval.
- Prepare IRB paperwork needed for study startup.
- Obtain RAC or IRB approval for amendments, protocol changes, and related activities.
- 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
- Assist the Division Administrator with the industry-sponsored budget proposal.
- Obtain the cost of services for all procedures, study visits, etc., related to the trial.
- Work with the Division Administrator to assess the study's financial feasibility.
- 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
