Key skills
LeadershipProject ManagementTime ManagementCollaboration
About this role
Role Overview
- Support and lead the management of multi-center clinical research studies
- Perform site monitoring visits for source document verification and assess site compliance
- Coordinate and provide support for all aspects of study including protocol and site management
- Develop and manage study metrics, providing training and mentorship to junior team members
- Analyze trends in identified issues and author visit reports and letters
- Oversee and manage operational aspects of clinical trial sites in conjunction with project teams
- Collect and review essential documents for investigational sites
- Serve as primary liaison for site management issues
- Lead and train others in reviewing study site data and data reports
- Perform all duties in compliance with standard operating procedures, federal guidelines, and other applicable laws
- Develop, maintain, and present clinical trial and project specific training materials
- Participate in training junior CRAs on moderately complex concepts, processes, and tasks
Requirements
- Bachelor’s degree in healthcare/science related field; or equivalent related experience and/or education
- Minimum of five years of experience conducting clinical research studies, with at least three years’ direct experience monitoring complex clinical research studies
- Advanced understanding of clinical research study processes, study design and/or protocol management
- Advanced knowledge of clinical trial monitoring procedures and clinical data reporting processes
- Strong knowledge base of medical terminology and anatomy/physiology
- Computer proficiency, including the use of standard software (word processing, databases, email) and use of internet
- Advanced project management, training, and conflict resolution skills
- Strong time management skills and problem-solving abilities
- Demonstrated leadership skills, fostering collaboration and motivating team members
Benefits
- medical, dental, vision, life and disability, accident/critical illness/hospital benefits
- well-being benefits
- legal benefits
- identity theft benefits
- pet benefits
- retirement plans
- paid time off/holidays
- leave
- incentive plans