Clinical Research Coordinator C (Department of Neurosurgery)

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Posted Job Title

Clinical Research Coordinator C (Department of Neurosurgery)

Job Profile Title

Clinical Research Coordinator C

Job Description Summary

This position will be a resource for best practices of managing major clinical trials. 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. They 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. Work with the regulatory manager to ensure that submissions to the IRB are completed in a timely manner.

Job Description

Job Responsibilities

• Coordinate Phase I-IV clinical trials
• Recruit, consent and screen patients according to protocol
• Schedule patient visits and any necessary testing. Monitor patients per protocol requirements and ensure adherence to protocol requirements
• Organize and maintain all required documentation- including source documentation, case report forms, and research charts. Collect, review and report study data, Complete case report forms and resolve data queries
• Process and ship study specimens including blood, urine and tissue samples
• Participate in the initiation, monitoring, audit, and close-out visits. Participate in study team meetings disease site group meetings, and ongoing protocol training/compliance meetings
• Develop/maintain study specific case report forms and source document tools
• Participate in the coordination of Phase I-IV clinical trials (10% Essential: 1),Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all other applicable review
• Other duties and responsibilities as assigned

Qualifications

• Bachelor of