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Mass General Brigham · 1 month ago

Clinical Research Associate/Coordinator I

Boston, MA

Full-time

Hybrid

Entry Level

$19.76/hr - $28.44/hr

1+ years exp

Mass General Brigham is a not-for-profit organization dedicated to advancing patient care, research, teaching, and community service. The Clinical Research Associate/Coordinator I will work under general supervision to consent and enroll patients in clinical research protocols, manage data collection, and coordinate patient appointments and communication.

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Responsibilities

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)

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

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 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

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

Ensure appropriate documentation of delegation and training for all study staff members

Maintain screening and enrollment documentation

Prepare monthly enrollment and data summary for study team

Qualification

Clinical research protocolsData managementPatient coordinationRegulatory managementAnalytical skillsComputer literacyCommunicationAttention to detailOrganizational skillsTeamwork