Clinical Research Associate II

Mass General Brigham • Boston, MA

3d • $24 - $39 • Remote

About The Position

The Multicenter Program within the Mass General Brigham Cancer Institute Clinical Trials Office seeks a Clinical Research Associate II to support the coordination and monitoring of investigator-initiated oncology clinical trials involving participating sites outside the Harvard Cancer Consortium. The Multicenter Program is an internal clinical trial operations team responsible for central coordination, monitoring, and regulatory oversight of these trials.

Under general supervision, the multicenter CRA supports trial coordination, maintains regulatory files, and monitors data, protocol compliance, and data quality across participating study sites. The position involves substantial correspondence, regulatory document coordination and tracking, and clinical data review. The CRA receives training in institutional and federal clinical research regulations. The role does not involve direct patient contact. Domestic travel is required for onsite monitoring visits.

Requirements

• Bachelor's degree.
• 1–2 years of related research experience.
• Ability to work independently and as a team member.
• High degree of computer literacy.
• Ability to interpret the acceptability of data results.
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
• Careful attention to detail.
• Superior organizational and time-management skills, including the ability to prioritize multiple tasks.
• Problem-solving skills, including the ability to gather information, identify resources, and develop alternatives.
• Excellent written and oral communication skills.
• Ability to demonstrate initiative and accountability.
• Ability and willingness to travel nationally.
• Working knowledge of clinical research protocols.
• Analytical skills and ability to identify and resolve problems and develop alternatives.
• Excellent judgment and ability to interpret information and protocol requirements.

Responsibilities

• Track trial progress across participating sites, including accrual, biospecimen collection and transfer, reportable events, and regulatory submissions.
• Correspond with participating sites to support trial activities.
• Answer questions about eligibility, study procedures, and data entry.
• Prepare and distribute informational updates, including meeting minutes, missing data reports, and safety reports.
• Communicate essential trial information and documentation, including protocol amendments, and request routine updates from sites to maintain current study status.
• Facilitate database reviews and query resolution.
• Present Sponsor-Investigator study status reports on trial progress and assigned tasks.
• Verify documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet inclusion and exclusion criteria.
• Conduct onsite and remote monitoring visits and complete monitoring reports.
• Perform source document verification and drug accountability.
• Review study-site regulatory binders and essential documents for completeness and accuracy.
• Evaluate ongoing protocol and data compliance.
• Issue, track, and resolve queries.
• Gather, track, and organize essential regulatory documents from participating sites.
• Facilitate and document Sponsor-Investigator review of safety reports, investigational drug brochure updates, study violations, and adverse events.
• Submit routine and expedited reports to the FDA, IRB, funding sponsor, or other stakeholders.

Benefits

• Competitive base pay.
• Comprehensive benefits.
• Career advancement opportunities.
• Differentials, premiums, and bonuses as applicable.
• Recognition programs designed to celebrate contributions and support professional growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level