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