Clinical Research Associate Senior

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Job Summary The Multicenter Program within the MGB Cancer Institute Clinical Trials Office is seeking candidates experienced in clinical trial coordination and implementation to support multicenter coordination and monitoring of investigator-initiated oncology clinical trials. The Multicenter Program is an internal clinical trial operations team, specializing in the central coordination, monitoring and regulatory oversight of MGBCI investigator-initiated clinical trials that are expanded to participating sites outside of the Harvard Cancer Consortium.

The Multicenter Senior Clinical Research Associate/Monitor (Sr. CRA) coordinates a portfolio of investigator-initiated multicenter clinical trials with limited project management support. The Sr. CRA oversees site activation, training, monitoring, and ongoing compliance while ensuring all regulatory requirements are met. This centralized trial coordination role does not involve 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, execution and completion.
· 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 activityo Devise and implement strategies to ensure operational and protocol complianceo Establish and track centralized procedures such as investigational drug shipment and biospecimens collection and processing .o

Anticipate, manage and prepare work products and deliverables 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
· Routinely update the Sponsor-Investigator of trial progress and any concerns with site performance
· Provide updates and new information to participating sites in a timely fashion
· Facilitate routine multicenter teleconferences and meetings
· Assemble study progress and safety reports for review boards and stakeholders
· 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
· Collect and interpret data necessary for enrollment; register patients appropriately
· Monitor and evaluate protocol and data compliance
· Conduct routine monitoring visits and close-out visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring visits)
· Perform source document verification and drug accountability
· Review study sites’ regulatory binders and essential regulatory documents for completeness and accuracy
· Facilitate site initiation visits and amendment training
· Prepare and update training materials

Regulatory responsibilities
· Ensure Federal…