[Remote] Clinical Research Associate I

Note: The job is a remote job and is open to candidates in USA. Mass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service. The Clinical Research Associate I will enroll patients in clinical research protocols and manage data collection and regulatory submissions for cancer studies, serving as a liaison between the clinical team, sponsor, and Institutional Review Board.

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

Skills

• 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

Benefits

• Comprehensive benefits
• Career advancement opportunities
• Differentials
• Premiums and bonuses
• Recognition programs designed to celebrate your contributions and support your professional growth

Company Overview

Company H1B Sponsorship