The Lead Clinical Research Associate (CRA) reports to and works closely with the studies under direction of the Project Manager and Senior Director of Clinical Operations to provide leadership to CRAs in study start-up activities, implementation, monitoring, and close-out activities of multiple clinical trials and process-improvement activities. The Lead CRA will also ensure that the Project Manager and Senior Director of Clinical Operations is aware of all monitoring metrics and critical issues. The Lead CRA is the key representative for monitoring responsibilities and assists assigned study monitors in maintaining relationships and rapport with clinical investigational site personnel.
- Knowledge of applicable SOPs, guidelines and study procedures
- Conducts trip report review for assigned projects
- Tracks visit and trip report metrics and summarize/report to teams
- Reviews site data quality trends via trip reports and data review including queries and protocol deviations
- Participates in CRA project-specific training
- Supports preparation and may develop materials related to the training and presentations for CRA training
- Develops Clinical Monitoring Plans
- Develops Monitoring tools and Source Document Templates
- Facilitates CRA project meetings
- Primary point of contact for Site Monitors working on a study
- Coordinate site monitor activities in partnership with the Project Manager
- Assist Project Manager and Quality team to ensure quality of field monitoring by conducting co- monitoring visits and performance assessment visits with Site Monitors
- Provides a key role in problem solving and issue escalation
- Mentors and co-monitors with CRAs on assigned teams
- Assists sites and data management with data query resolution
- May be responsible for a geographic area and travel as required by study needs to conduct site initiation visits, interim monitor visits, close-out visits, or unblinded monitoring visits
- Focus on meeting enrollment timelines and developing subject recruitment strategies
- Support business development team in building monitoring assumptions for RFPs
- Participate in TCTM bid defenses for potential projects
- Miscellaneous duties, as necessary, in support of Clinical Monitoring initiatives and TCTM business priorities and objectives.
- Requires a minimum of a Bachelor’s Degree, preferably in a scientific, healthcare, or related field.
- Requires a minimum of eight (8) years’ monitoring and site management at either a CRO or pharmaceutical/biotech company.
- Two (2) years of Lead or Senior CRA experience is required.
- CRA certification preferred.
- Must have a valid driver’s license
- Willingness and ability to travel up to 40% of the time
- Excellent oral and written communication, organizational and planning skills
- Thoroughness and dealing with complexity
- Proficiency with Microsoft Office Suite
To apply, please send a copy of your resume/cover letter to firstname.lastname@example.org with Lead CRA as the subject