Remote Oncology Clinical Trials CRA II

Mass General Brigham (Enterprise Services); Boston (MA); Remote; USD 33,000 - 54,000; Full time

Job summary

Mass General Brigham Incorporated seeks a Clinical Trials Coordinator for the Multicenter Program in the Cancer Institute Clinical Trials Office. This role supports multicenter coordination, regulatory oversight, data review, and trial monitoring across sites, with no direct patient contact.

Responsibilities include tracking accrual, regulatory submissions, site communications, source data verification, GCP compliance, and travel for on-site visits as needed.

Qualifications

• Bachelor's degree required.
• 1-2 years related research experience required.
• High degree of computer literacy and data review skills.

Responsibilities

• Track the progress of the trial across all participating sites (accrual, biospecimen collection and transfer, reportable events, regulatory submissions).
• Correspond with participating sites to support trial activities as needed.
• 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; request routine updates from sites to maintain current study status.
• Facilitate database reviews and query resolution.
• Present the Sponsor-Investigator study status reports related to trial progress and assigned tasks.
• Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria.
• Conduct onsite and remote monitoring visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring).
• Perform source document verification and drug accountability.
• Review study site regulatory binder 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

Skills

Independent work

Team player

Attention to detail

Excellent communication

Time management

Problem solving

National travel

Clinical research knowledge

Education

Bachelor's Degree

Job description

Mass General Brigham Incorporated seeks a Clinical Trials Coordinator for the Multicenter Program in the Cancer Institute Clinical Trials Office. This role supports multicenter coordination, regulatory oversight, data review, and trial monitoring across sites, with no direct patient contact.

Responsibilities include tracking accrual, regulatory submissions, site communications, source data verification, GCP compliance, and travel for on-site visits as needed.