Note: The job is a remote job and is open to candidates in USA. Mass General Brigham is hiring a Clinical Research Associate II for its Cancer Institute Clinical Trials Office Multicenter Program. The role supports coordination, monitoring, regulatory oversight, and data and protocol compliance for investigator-initiated oncology trials conducted across participating sites.

Responsibilities

• Track the progress of the trial across all participating sites (e.g., 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

• Bachelor's Degree required
• Related research experience 1-2 years 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 and 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
• Demonstrate initiative and accountability
• 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

Benefits

• Remote work
• Comprehensive benefits
• Career advancement opportunities
• Differentials
• Premiums
• Bonuses, as applicable
• Recognition programs

Company Overview

Company H1B Sponsorship