Description
This role is a great opportunity to get clinical experience with a sponsor company and field monitoring work.Role:
- Monitors clinical studies and sites for adherence to protocol, GCP and Monitoring Plan
- Prepares study related documents including Informed Consent Forms (ICFs), draft source documents, Study Reference Binders, and Case Report Forms (CRFs)
- May serve as a primary sponsor contact for multiple clinical sites
- Tracks essential documents; files documents in Trial Master File (TMF)
- Works with the Clinical Project Manager and helps support all clinical requirements
- Prepares reports/presentations for the Clinical Director and CMO
Requirement:
- RN degree preferred; BS or equivalent degree also accepted
- 3+ years of clinical trial experience
- Highly Preferred - Experience as a Clinical Coordinator in a Womens Health Clinical and/or urology
- Ability to travel 50% for regional monitoring visits
- Strong communication skills