Lead Clinical Research Associate

We are OperationsInc, a human resources consulting firm located in Norwalk, CT. Since 2001, OperationsInc has been supporting a base of over 1,000 clients with their diverse and evolving HR needs. Our client, an oncology based research company, located in Westchester County is looking for a Lead Clinical Research Associate.

RESPONSIBILITIES:

The Lead Clinical Research Associate (LCRA) is responsible for the performance of assigned Field Based Clinical Research Associates (CRAs) and investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Trial Manager (CTM). Additional responsibilities include implementation of enrollment and recruitment strategies, preparation of the monitoring plan, oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The LCRA will develop study tools for sites and CRA use, review trip reports, review and track protocol deviations, and support other objectives for the clinical operations department.

The primary responsibilities for the LCRA include:

•Oversight of field monitors and site activities in accordance with the Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
•Develop, execute, manage and ensure compliance of the Monitoring Plan.
•Review trip reports and track scheduling, report submission metrics, site deviations and action items.
•Manage site and monitoring issue prevention, escalation, and corrective actions.
•Develop training materials and study tools for sites and CRAs use.
•Develop and implement enrollment and recruitment strategies.
•Support other objectives for the clinical operations department (i.e., Safety Report distribution and process development)