Clinical Research Associate/Clinical Research Coordinator I

Site: The General Hospital Corporation

 

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

 

The Translational Clinical Research Associate/Clinical Research Coordinator works under general supervision to consent and enroll eligible patients to clinical translational research protocols and manage all aspects of data collection and requests. In particular, the CRA/CRC I will work on specimen collection studies. The Translational CRC/CRA will work closely with multiple providers to support their translational research projects. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact. This is an on-site/hybrid position. Duties will be performed primarily on-site in ambulatory/clinical office setting. Components of the data/regulatory role may allow for remote work.

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

The following clinical duties will be performed:

• Interfacing in a professional manner with a diverse team of physicians, clinical research assistants, research nurses, pathologists and patients
• Coordinating the collection and processing of tissue samples and blood samples from patients
• Consent patients to translational research studies (minimal risk specimen collection studies)
• Explain study protocol to patients and obtain informed consent
• Screen and follow patients relevant to specific projects/studies
• Assist clinical team in screening potential patients for study participation
• Schedule all protocol required tests and procedures
• Consent patients to specimen collection protocols
• 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 blood and tissue samples
• Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL)


The following data management responsibilities will be performed:

• Collecting detailed clinical and treatment information on patients who are undergoing genetic testing, receiving treatments for cancer, or are enrolled in a research study
• Maintaining an updated and organized database of patients
• 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.
• 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
• Facilitate the request and shipment of samples
• Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
• Assist in abstracts, presentations, and manuscripts

The following regulatory duties may be performed:

• Assist with new study submission
• Assist with updates and/or changes to current 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 requir