Description
Primary Responsibilities:- 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
- Has experience as clinical operations lead on a significant Phase II or Phase III program
- Independently designs study related documents
- Support of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directed
- Leads study management team meetings and teleconferences with study vendors
- Manages study-specific CROs and vendors and contract CRAs as appropriate
- Performs monitoring of sites as required by needs of project with minimal guidance or supervision
Skills / Experience:
- BA/BS in science-related field with a minimum of 4 years work experience as a CRA or CTM (or combination of relevant related work experience)
- Excellent written and verbal communication skills required
- Demonstrated thorough understanding of FDA regulations and GCP.
- Well-developed and strong problem solving skills
- Exceptional interpersonal skills with demonstrated successful team participation.
- Proficient in 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