Clinical Operations Associate
Under general guidance, provide support to the clinical team in all aspects of clinical trial operations
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:
Support Study Manager/Director by independently performing assigned clinical operations tasks from study start-up through study execution and closeout.
Contribute to study team meetings by providing study updates and writing meeting minutes
Assist in the planning, organizing and executing project-specific meetings
Participate in vendor management/oversight
Perform monitoring and co-monitoring visits, as necessary
Develop and maintain/oversee study tracking reports and study tools
Track enrollment and follow up on outstanding information
Oversee study tracking to ensure documents are accurate, current and complete
Assist with resolution and communication of investigational site Protocol Deviation Forms
Assist with overseeing tasks performed by Clinical Trial Assistant(s)
Establish collaborative relationships with colleagues in Clinical Development, Regulatory Affairs and throughout the Company
Perform additional tasks and duties as assigned
Knowledge of FDA regulations, Good Clinical Practices, and ICH Guidelines. Must have excellent organizational skills and be detail-oriented. Able to work independently and to function as a team player. Able to manage/prioritize own work. Must have excellent interpersonal skills and excellent communication skills (verbal and written). Computer proficiency required.
EDUCATION and EXPERIENCE:
BS, MS, or RN with 3-5 years of clinical trial experience working at a biotech/pharmaceutical company or CRO including a minimum of 1 year of independent monitoring experience. In some cases, a combination of education and prior directly related experience may be considered as equivalent.