Clinical Research Coordinator C

Job Description Summary

This position will be a resource for best practices of managing NIH and Industry-sponsored clinical trials in the Neuroradiology Clinical Research Division. The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and sponsor. He/She will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. Will problem-solve the challenges to implement a plan of action; will work with the project manager to ensure study procedures and regulatory submissions are completed in a timely manner. Will assist in the supervision and execution of research trials with the staff to ensure adherence to the protocol is followed and will audit the trials for compliance and enrollment which include a review of the data entry for accuracy and completeness and adverse event management. The coordinator will take an active role in study start-up through closeout, and preparation of trial audits and inspection. The coordinator will take a lead role supervising any inspection that takes place with the trials.

Additional responsibilities include assistance with study coordination for research trials and other research activities to include site selection preparation, organizing and maintaining study documentation, database entry, resolving data queries, review of medical records, scheduling study-related tests in EPIC/Pennchart, Radiology, and other research systems; preparing and processing regulatory documents for submission to the IRB, and all regulatory committees from study start-up to completion. Interact with study sponsors, preparing and participating in study initiation visits, study audits, monitoring, and closeout visits. Perform other duties as assigned.

Job Responsibilities

• The coordinator will provide guidance to both study trials and device trials. The incumbent will be a liaison to departmental interaction such as the investigational team, the nursing units and sponsor. He/She will be a resource to other members of the team and will oversee the implementation of new clinical trials. Will review all new trials to help identify the challenges and opportunities discovered. The coordinator will assist other research staff with participant recruitment and study coordination in the Neuroradiology Clinical Research Division. Organize and maintain study documentation, preparing and processing regulatory documents for submission to the IRB, and all regulatory committees from study start-up to completion. Data transfer and collection of imaging data for preparation of processing and analysis.
• Will problem-solve the challenges to implement a plan of action; will work with the project manager to ensure study procedures and regulatory submissions to the IRB are completed in a timely manner. Will supervise the execution of the trial with the staff to ensure adherence to the protocol is followed and will audit the trials for compliance and enrollment which include a review of the data entry for accuracy and completeness and adverse event management. The coordinator will take an active role in preparation of trial audits and inspection. The coordinator will take a lead role supervising any inspection that takes place with the trials. S/he will provide monthly updates to the research team, and the director of clinical research in the division.
• Other duties and responsibilities as assigned
• Contingent upon Grant Funding