Lead Clinical Research Associate - New York

Employment Type

: Full-Time


: Scientific Research

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The Lead Clinical Research Associate (LCRA) reports to and works closely with the Director of Clinical Operations and Project Manager to provide leadership to CRAs in study start-up activities, implementation, monitoring, and close-out activities of multiple clinical trials and process-improvement activities. This individual should have the ability to mentor and train a team of CRAs and provide close project oversight with demonstrated problem-solving skills. The Lead CRA will also ensure that Director of Clinical Operations is aware of all monitoring metrics and critical issues. This position will review monitoring trends, track monitoring deliverables, review trip reports, and recommend potential solutions to identified issues. The Lead CRA may actively participate in monitoring large, complex study(ies) and clinical trial activities from study start-up through closure and is expected to attend team meetings, Investigator Meetings, support business development efforts, and manage site assignments.

1. Conducts trip report review for assigned projects within specified timelines.

2. Tracks visit and detailed trip report metrics and summarize/report to teams.

3. Reviews site data quality trends via trip reports and data review including queries and protocol deviations.

4. Participates in CRA project-specific training.

5. Supports preparation and may develop materials related to the training and presentations for CRA training, Site Initiation Visits and Investigator Meetings.

6. Develops Clinical Monitoring Plans, Monitoring tools and Source Document Templates.

7. In conjunction with Clinical Operations leadership may assist in developing and testing EDC, and eTMF functionality (UAT testing).

8. Conducts periodic repeating CRA one-on-one meetings.

9. Provides a key role in problem solving and issue escalation, regarding specimen collection and shipping, monitoring issues with proposed solutions to the Director of Clinical Operations.

10. Mentors and may co-monitor with CRAs on assigned teams.

11. May conduct all types of clinical monitoring visits when required, e.g. (pre-study qualifications, initiations, on site and remote monitoring, and close-out) which includes all preparatory and follow-up aspects.

12. Monitors site performance and compliance and provides management with necessary reports, updates and recommendations.

13. Mentors/assists CRAs in preparing clinical sites for regulatory agency audits.

by Jobble

Associated topics: alcohol test, assay, intern, lab, lab support, lab technician, laboratory, routine care, sample collection, scientific associate

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