The Multi-Center Senior Clinical Research Associate/Monitor (Sr. CRA) works independently, under minimal supervision, to initiate, manage and navigate a portfolio of Investigator-initiated, multi-center clinical research trials. Specifically, the Sr. CRA will carry out the activation, training, monitoring and oversight of participating institutions while also supporting and ensuring compliance with the regulatory responsibilities of the Sponsor Investigator. This role focuses on centralized trial coordination and does not include direct patient contact.
Principal responsibilities include:
Trial and portfolio coordination
• Provide comprehensive trial coordination from pre-activation to study closure; ensure timely and efficient protocol initiation and execution
• Coordinate, track and streamline key milestone achievements and overall progress of the trial across all participating sites:
o Document seminal events from pre-activation to closure; use program templates and tools to organize cumulative data and cyclic events such as enrollment, reportable events, continuing review, safety reporting, etc.
o Direct site onboarding and activation and maintain continuous oversight of study site activity
o Devise and implement procedures to ensure operational and protocol compliance
o Establish and track centralized procedures such as shipment of investigational drug and collection and processing of biospecimens.
o Anticipate, manage and prepare work product and deliverable within appropriate due dates and deadlines
• Maintain and amend protocol documents as applies; ensure version control across sites
• Act as central communications liaison for all clinical trial collaborators
o Routinely update the Sponsor-Investigator of trial progress and any concerns with site performance
o Provide updates and new information to participating sites in a timely fashion
o Facilitate routine multi-center teleconferences and meetings
o Assemble study progress and safety reports for review boards and stakeholders
o Effectively troubleshoot questions or setbacks regarding trial progress as they arise
Site Monitoring and Training
• Verify patient eligibility via source document review and clinical analysis of case data
o Collect and interpret data necessary for enrollment; register patients appropriately
• Monitor and evaluate protocol and data compliance
o Conduct routine monitoring visits and close-out visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring visits)
o Perform source document verification and drug accountability
o Review study sites’ regulatory binders and essential regulatory documents for completeness and accuracy
• Facilitate site initiation visits and amendment training
o Prepare and update training materials
Regulatory responsibilities
• Ensure Federal and local Sponsor-Investigator regulatory responsibilities are met
o Maintain electronic Trial Master File and Site Specific Files
o IND management; compose and submit FDA investigator amendments, protocol amendments, safety reports, annual progress reports, etc.
o Provide reportable events to regulatory entities and stakeholders on behalf of participating sites
Program responsibilities
• Train and orient new/junior staff; provide leadership and guidance within and across program teams
• Negotiate increasingly complex clinical trial attributes
• Assimilate and report study metrics and timelines to program management
• Contribute to continuous quality assurance initiatives within the program Experience
Skills Required
Working Environment
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