Mass General Brigham · 23 hours ago
Clinical Research Associate I
Mass General Brigham is a not-for-profit organization dedicated to advancing patient care, research, teaching, and community service. The Clinical Research Associate I (CRA I) will work under supervision to enroll patients in clinical research protocols and manage data collection and regulatory submissions for cancer studies, acting as a liaison between clinical teams and sponsors.
Health CareHome Health CareMedical
Responsibilities
Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
Enroll patients as required by the study sponsor and internal enrollment monitor team
Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements
Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
Maintain research charts and/or electronic files for all enrolled patients
Ensure adequate source documentation is in place for all data reported
Resolve data queries issued by the sponsor
Obtain protocol clarifications from the study sponsor and communicate information to the research team
Schedule and prepare for monitoring visits with sponsors
Organize and prepare for internal and external audits
Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
Maintain and organize study specific regulatory binders
Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
Submit Data and Safety Monitoring Reports
Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
Collect, complete, and submit essential regulatory documents to various regulatory entities
Participate in monitoring visits and file all monitoring visit correspondence
Ensure appropriate documentation of delegation and training for all study staff members
Maintain screening and enrollment logs
Qualification
Required
Bachelor's Degree Related Field of Study required
Careful attention to detail
Good organizational skills
Ability to follow directions
Good communication skills
Computer literacy
Working knowledge of clinical research protocols
Ability to demonstrate respect and professionalism for subjects' rights and individual needs
Preferred
Research Related Experience 1-2 years preferred
Attention to detail
Ability to recognize compliance and data integrity issues and respond appropriately
Knowledge of medical terminology
Ability to communicate effectively with patients, vendors, contract research organizations and professional staff
Effective interpersonal and communications skills
Benefits
Comprehensive benefits
Career advancement opportunities
Differentials
Premiums and bonuses
Recognition programs designed to celebrate your contributions and support your professional growth
Company
Mass General Brigham
Mass General Brigham specializes in providing medical treatments and health diagnostics services.
H1B Sponsorship
Mass General Brigham has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (77)
2024 (61)
2023 (93)
2022 (70)
2021 (80)
2020 (29)
Funding
Current Stage
Late StageLeadership Team
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