Clinical Research Associate II

Mass General Brigham•Boston, MA

2d•Remote

About The Position

The Multicenter Program within the Mass General Brigham Cancer Institute Clinical Trials Office seeks a Clinical Research Associate to support the coordination, monitoring, and regulatory oversight of investigator-initiated oncology clinical trials expanded to participating sites outside the Harvard Cancer Consortium. Under general supervision, the CRA supports trial coordination, maintains regulatory files, and monitors data, protocol compliance, and data quality across participating sites. The position includes substantial correspondence, regulatory document coordination and tracking, and clinical data review. The CRA receives training in institutional and federal regulations governing clinical research. There is no direct patient contact. The role reports to the Clinical Research Manager and requires national travel, including domestic travel for onsite monitoring visits. The position is remote, based at the listed work location of 101 Merrimac Street, and scheduled for 40 hours per week on the day shift.

Requirements

Bachelor's degree required.
One to two years of related research experience required.
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 gathering information, identifying resources, and developing alternatives.
Excellent written and oral communication skills.
Demonstrated 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 and answer questions about eligibility, study procedures, or 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 site updates to maintain current study status.
Facilitate database reviews and query resolution.
Present Sponsor-Investigator study status reports covering trial progress and assigned tasks.
Verify documentation of consent, required screening tests and procedures, and eligibility criteria to confirm patients meet inclusion and exclusion criteria.
Conduct onsite and remote monitoring visits and complete corresponding 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.