Title: Clinical Trial Coordinator (In-House)
Reporting To: Clinical Trial Manager (CTM)
Responsible for coordination of ongoing clinical trials and clinical activities. Administrative support for Clinical and Regulatory Affairs.
Works within guidelines established by the VP of Clinical and Regulatory Affairs. Maintains overall awareness in the field of clinical research. Understands SOPs, GCP, and FDA, IRB and local regulations. Seeks supervision as needed within the bounds of established practices and policies.
- Administration of ongoing clinical studies including: maintenance of current regulatory documentation according to Regulatory Guidelines; maintenance of Trial Master File (TMF) and clinical trialsite files
- Supports the CTM in management of study device accountability; ordering and tracking of study supplies; and tracking study-related expenses.
- Creation and maintenance of electronic library.
- Creation of study-related documents and trackers, as needed
- Preparing and distributing clinical trial site Regulatory and Site Binders.
- Communicate with study sites on collection of study related documents
- Participation in generation of weekly status reports.
- Provides administrative assistance such as event and meeting planning
- Other duties as assigned.
- 1-3 years experience in a clinical trial environment as clinical coordinator, or equivalent with clinical trial conduct knowledge;
- Excellent knowledge of Microsoft Office suite (Word, Excel, PowerPoint);
- Excellent organizational skills, ability to handle multiple tasks to meet deadlines with attention to detail;
- Strong interpersonal skills as well as willingness to work within a team-oriented environment
Requires BA / BS in the science/health care field or equivalent related experience.