Independently manage initiation, maintenance and close-out activities of multi-center clinical studies ensuring compliance with protocol, SOPs, ICH GCP and regulatory/local requirements
Plan and procure team resources to complete study activities according to scope, budget, and timeline
Develop and/or oversee study plans (project management, monitoring, risk management, data management, safety)
Coordinate activities with central laboratories and other external service providers/vendors
Review and negotiate site budgets and contracts and participate in change orders to sponsor/site contracts and budgets
Maintain effective communication with sponsor, external service providers, and internal departments to ensure successful project completion
Requirements
Bachelor's degree required, preferably in science, nursing, other biomedical discipline, or equivalent
Clinical research experience as a CRA or Research Coordinator is preferred
Experience in support of business development processes, including budgets, proposals and bid defense planning and execution
Ability to work across multiple projects
Experience with renal and hepatic impairment, infectious disease and tobacco studies is an asset
Flexible and willing to travel up to 30% (regional)
Excellent problem-solving and decision making skills
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.