Description
Responsibilities:- Oversee 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 II 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.
- 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.
Education / 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.
- Excellent written and verbal communication skills required.Demonstrated thorough understanding of FDA regulations and GCP.
To find out more about Real please visit www.realstaffing.com