Clinical Research Associate Senior

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

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.
• 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.
• Direct site onboarding and activation and maintain continuous oversight of study site activity.
• Devise and implement strategies to ensure operational and protocol compliance.
• Establish and track centralized procedures such as investigational drug shipment and biospecimens collection and processing.
• 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 and local Sponsor-Investigator regulatory responsibilities are met.
• Maintain electronic Trial Master File and Site Specific Files.
• IND management; compose and submit FDA investigator amendments, protocol amendments, safety reports, annual progress reports, etc.
• 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.

Skills/Abilities/Competencies Required

• Ability to independently and effectively coordinate a portfolio of clinical trials.
• Exceptional time management skills with the capacity to prioritize among multiple tasks.
• Excellent written and verbal communication skills.
• Ability to interpret acceptability of data results and identify incorrect or incongruent data.
• Able to work successfully in a remote environment and demonstrate initiative and accountability.
• Motivated to help team achieve results and meet deadlines.
• Problem-solving skills, including the ability to gather information, identify resources, and develop alternatives.
• Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP).

Qualifications

Education: Bachelor's Degree required. Experience: 2-4 years related experience required.

Knowledge, Skills and Abilities

• Excellent written and verbal communication skills.
• Knowledge of current and developing clinical research trends.
• Sound interpersonal skills and the ability to mentor others.
• Ability to work independently and display initiative.
• Ability to identify problems and develop solutions.
• Demonstrated ability to successfully manage multiple projects.
• Established rapport with investigators and sponsors with the ability to resolve operational matters within a disease group.