Summary: Functions in a leadership capacity over the monitoring function and monitoring team. May have traditional site monitoring responsibility but also serves as an assistant to the Clinical Research Manager. Has mastered the clinical monitoring process, associated competencies and understands the role of clinical research in drug development. Is an expert on relevant Clinical Practice (GCP), FDA regulatory requirements, and Standard Operating Procedures (SOPs).
- Takes a lead role in training and mentoring CRAs.
- Responsible for timely Monitor Visit Report review per required review metrics, standards outlined in Monitoring Plan for each study; communicate report comments/issues to appropriate CRA for report edits. If applicable, address with CRA need for site re-education.
- Ensure issues and deviations are noted and tracked appropriately in reports and follow-up letters.
- Serve as a resource for monitoring questions and triage questions to other team members as appropriate.
- Manage monitoring report timeliness metrics and ensure CRAs are in compliance with applicable SOPs and monitoring plans.
- Communicate to Study Management monitor trends (queries, protocol deviations), site issues (i.e. enrollment barriers, etc) which may require further attention.
- Review and manage monitoring calendar to ensure adherence to agreed monitoring visit windows and time on site needs.
- Function as primary monitor for one site on assigned projects and co-monitor as needed.
- Review data management report to ensure queries are being resolved in a timely manner and review data for trends as applicable.
- Assists in collection and assessment of clinical essential documents.
- Creates and/or reviews all monitoring tools and train others to develop them.
- Prepare weekly status reports for study manager.
- Performs pre-study, initiation, interim monitoring and close out visits according to applicable SOPs, GCP and FDA Guidelines.
- Assists other team members with site-specific issues, acting as liaison between study staff and project staff.
- This position requires a B.S./B.A. or equivalent years of work experience with 3 or more years of experience in the clinical research or pharmaceutical industry, or equivalent combination of education and experience. (Experience in ophthalmology preferred.)
- Must have mastered all core competencies of the Clinical Research Associate.
- Exceptional organizational and management skills with the keen ability to prioritize multiple tasks with attention to detail.
- Outstanding communication, both written and verbal skills, personable, able to develop a positive rapport with clinical sites and to lead and train, as needed other Clinical Research Associates.
- Uses discretion and good judgement to address potential problems, elevating concerns to the next level of management when necessary. Understands clinical monitoring process, and understands the role of clinical research associates in pharmaceutical drug development. Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance.
- Some project travel is required.
Skills & Attributes:
- Must be highly customer service oriented and have creative initiative with a positive attitude.
- Understands and shares the organizational values of developing and maintaining good relationships internally and externally. Quality of interactions reflects emphasis on relationships.
- Strong communication (both written and verbal), personable, able to develop a positive rapport with clinical sites.
- Applies good judgment to address potential problems, elevating concerns to the next level of management when necessary.
- Strong attention to detail.
- Strong computer and organizational skills.
- Proficiency in some software system(s) as appropriate for needs of department required.