Description
Job Description:- 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 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.
- 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.
- Adds insight regarding evaluation and selection of CRO's, contractors and other outside vendors.
- Coordinates efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operations staff as appropriate.
- Works with Financial Operations Coordinator on vendor and study site budget tracking and compliance.
- Uses well-developed problem-solving skills to address needs of program and may provide guidance to other lower level personnel.
Requirements:
- BA/BS in science-related field with a minimum of 4 years work experience as a CRA or CRA/CTM combination of relevant related work experience.
- Cardiology
- global study experience
- Vendor management
- Involvement in protocol development.
To find out more about Real please visit www.realstaffing.com