Clinical Research Associate/Coordinator I

Mass General Brigham•Boston, MA

2d•$20 - $28•Hybrid

About The Position

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.

Requirements

Ability to be self-motivated to work independently and as a team member
Analytical skills and ability to resolve problems
Careful attention to detail
Excellent organizational skills
Ability to follow directions
Excellent verbal and written communication skills
Computer literacy
Working knowledge of clinical research protocols
Ability to demonstrate respect and professionalism for subjects rights and individual needs
Bachelor's Degree Related Field of Study required

Nice To Haves

Clinical Research or compliance experience 1-2 years preferred
Ability to work independently and as a team member.
Analytical skills and ability to resolve problems.
Ability to interpret acceptability of data results.
Careful attention to detail.
Good organizational and communication skills.
Working knowledge of clinical research protocols.

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