JOB DESCRIPTION
Job Title:
Senior Clinical Research Associate
Department:
Clinical Affairs
Revision Date:
August 25, 2022
Job Summary
Responsible for the day-to-day activities related to the initiation and implementation of clinical investigations. Manage multiple clinical sites to assure compliance with GCP, the investigational plan and relevant regulations. Manage study documentation for completeness and accuracy, track study progress, monitor data, and develop recruitment strategies as needed.
Receives Direction From
Vice President Clinical & Regulatory Affairs; Director, Clinical Affairs
Provides Direction To
Contract monitors
Essential Job Functions and Responsibilities
- Oversee clinical trial start-up activities including investigator identification, shipment of clinical study supplies and investigational product, and collection of in-house clinical study files
- Coordinate with investigative sites for IRB approval and ongoing clinical trial execution activities, including site visits, maintain communication with sites for support on regulatory documents and vendor needs, oversee device accountability, and ensure adequate supply at clinical sites, support EDC activities, and development of study tools and aids
- Perform on-site training and support for study staff, including proctored clinical cases, if required
- Complete site visits to verify case report forms for accuracy and completeness, ensure regulatory binder completeness and liaising with the study site
- Remotely monitor data and support clinical sites for protocol compliance and recruitment activities
- Manage clinical trial close-out activities, including return of investigational product, final reconciliation of all required documentation, and EDC close-out
- Develop and maintain a working knowledge of relevant protocols
- Participate in database lock activities, annual/final report creation, and preparation of regulatory submissions
- Attend courses, seminars, meetings, as required
- Travel as necessary, up to 70%
- Perform other duties, as assigned
Qualification Guidelines
- Minimum 4 years relevant work experience in clinical research with experience in surgical ophthalmology and medical devices, experience in glaucoma devices preferred
- Bachelor’s degree in biological/health sciences, or equivalent, including relevant clinical research experience
- Excellent written and verbal communication skills and organizational skills
- Motivated and able to work independently, as well as within a team
- Knowledge of medical and ophthalmology terminology