Clinical Research Associate/Coordinator I

Principal Duties and Responsibilities

All duties will be performed under general supervision by the Clinical Research Manager.

Clinical Duties

• Assist clinical team in screening potential patients for study participation
• Obtain informed consent for sample and data collection protocols
• Schedule all protocol required tests and procedures
• Coordinate patient appointments with physicians, nurses, and all test areas
• Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers
• Prepare pre-visit communication for providers to ensure required assessments are completed and documented
• Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation
• Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition
• Coordinate, obtain, process, and ship protocol required tissue samples
• Ensure collection and processing (e.g. spin/separate/freeze) and storage of all required correlative research blood and tissue samples
• Administer quality of life assessments as required for individual studies

Data Management 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
• Facilitate the request and shipment of archival pathology samples
• Organize and prepare for internal and external audits
• Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies

Regulatory Duties

• 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/Abilities/Competencies 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

Working Conditions

• Duties will be performed primarily on-site in ambulatory and laboratory setting
• Duties will be performed at both Massachusetts General Hospital and Brigham and Women's Hospital
• Components of the data/regulatory role may allow for remote work