Description
Essential Job Functions:- Requires minimal supervision to manage various activities associated with multiple clinical studies in accordance with designated project assignments
- Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct
- Has had experience as clinical operations co-lead/lead on a significant Phase I or Phase III program
- Independently designs study related documents including but not limited to: clinical protocols, case report forms, site study manuals and project tools, monitoring plans, tracking tools, informed consent forms
- Support of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directed
- Manages study-specific CROs and vendors and contract CRAs as appropriate
- Leads study management team meetings and teleconferences with study vendors
Requirements:
- BA/BS in science-related field with a minimum of 4 years years work experience as a CRA or CRA/CTM combination of relevant related work experience
- Demonstrated thorough understanding of FDA regulations and GCP
- Excellent written and verbal communication skills required
- Proficient in use of Microsoft applications such as Word, Excel, Power Point, etc
- Ability to travel important as the position could require approximately 25% time spent in business travel
To find out more about Real please visit www.realstaffing.com