Lead Clinical Research Associate

Title: Lead Clinical Research Associate

Location: Raritan, NJ 08869

Responsibilities: 

LEAD CLINICAL RESEARCH ASSOCIATE:

Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities 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 Project Lead (CPL).

Additional responsibilities include:

• Implementation of enrollment and recruitment strategies

• Assistance in vendors’ selection processes

• Development, execution, management and compliance assurance of the Monitoring Plan

• Review and approve trip reports, track scheduling, report submission metrics, site deviations and action items

• Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.

• Development of training materials and study tools for site and CRA use

• Assistance in formation of the Adjudication Committee including oversight of documentation collection and filing into the Trial Master File