The Department of Medicine, Division of Pulmonary is seeking a full time Clinical Research Coordinator II. This position will function as a clinical research team member, coordinating and completing assigned clinical research activities under the direction of the Principal Investigator and Assistant Director of Research. The incumbent will assist in conducting clinical trials/clinical research within the Division of Pulmonary, Critical Care & Sleep Medicine, ensuring compliance with federal, state, and university policies. This role requires strong organizational, problem-solving, and communication skills.

Essential functions;

Clinical Trial Project Management

Support the Pulmonary Medicine principal investigator with industry-sponsored clinical trials or internally funded clinical research. Screen and enroll patients into clinical trials following protocol guidelines. Schedule study visits and ensure appropriate follow-ups. Visit frequently with the study monitor to ensure compliance with industry protocol guidelines. Ensure compliance research database (OnCore) management. Process patient stipends and manage study-related documentation. Assist the Assistant Director of Research with any internal/external audits or other tasks, as assigned. Receive and process any updates on protocol changes, upcoming amendments, etc. Work with the Assistant Director of Research to respond to new industry-sponsored solicitations.  Regularly review research study billing to ensure compliance. Maintain communication with study sponsors, monitors, regulatory bodies, and internal teams.

- Clinical trial regulatory management

Under supervision, assist with preparing institutional and regulatory paperwork needed for study startup approval. Under supervision, obtain RAC or IRB approval related to amendments, protocol changes, etc. Comply with all institutional, federal, state, sponsor, and Divisional policies. Work with the Assistant Director of Research to appropriately retain records/archive documents after study closeout. Ensure that informed consent documents are properly executed and recorded in the EMR.

Clinical Trials budget

Assist the Assistant Director of Research and Clinical Research Manager with industry-sponsored budget proposals. Obtain the cost of services for all procedures, study visits, etc., related to the trial. Work with the Assistant Director of Research and Clinical Research Manager to ensure the financial feasibility of the study.  Track study-related expenses and assist with financial documentation. Assist in preparing financial reports related to clinical research studies.

- This position will perform ad hoc assignments as assigned by the Assistant Director of Research. Attend research meetings and trains as assigned. Provide general support to the clinical research team

Preferred qualifications: Experience in clinical research coordination, preferably in pulmonary or critical care studies. Knowledge of OnCore, EPIC, and REDCap systems. Strong interpersonal skills and ability to manage multiple tasks efficiently. Familiarity with Good Clinical Practice (GCP) guidelines and regulatory compliance. Can carry out spirometry under supervision.