Clinical Research Associate/Coordinator I

Mass General Brigham•Boston, MA

4d•Onsite

About The Position

The Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients in clinical research protocols and manage data collection and submission for multiple cancer studies. The role serves as a liaison between the clinical team, study sponsors, and the Institutional Review Board (IRB), supporting appropriate communication and reporting. The employee receives training on institutional and federal regulations governing clinical research. The work combines data abstraction and entry, regulatory management, and patient coordination, and includes direct patient contact. Clinical responsibilities include screening potential participants, coordinating appointments and protocol-required tests and procedures, supporting patient communication, and coordinating the collection, processing, and shipment of study samples. Data management responsibilities include verifying eligibility and documentation, enrolling patients, monitoring protocol compliance, entering and validating study data, reporting adverse events and deviations, resolving sponsor queries, and preparing for monitoring visits and audits. Regulatory responsibilities may include maintaining study files, preparing and submitting IRB materials and safety reports, managing required documentation, and supporting regulatory monitoring.

Requirements

Bachelor's degree required; experience cannot be substituted for the degree.
Ability to work independently and as a team member.
Analytical skills and ability to resolve problems.
Ability to interpret the acceptability of data results.
Careful attention to detail.
Good organizational and communication skills.
Working knowledge of clinical research protocols.

Nice To Haves

One to two years of clinical research or compliance experience preferred.

Responsibilities

Assist the clinical team in screening potential patients for study participation.
Schedule protocol-required tests and procedures and coordinate patient appointments with physicians, nurses, and testing areas.
Coordinate clinical safety laboratory specimen draws and ensure timely results are available to providers.
Prepare pre-visit communications for providers to support completion and documentation of required assessments.
Maintain point-of-contact communication with enrolled patients and address front-line questions about study participation.
Develop protocol-specific flow charts, intake sheets, and other tools to support protocol compliance and data acquisition.
Coordinate, obtain, process, and ship protocol-required tissue samples.
Coordinate collection and processing of correlative research blood samples with the MGH Sample Processing Lab.
Obtain vital signs, perform EKGs, and administer quality-of-life assessments when required by individual studies.
Verify consent documentation, screening tests and procedures, and eligibility criteria.
Enroll patients as required by study sponsors and the internal enrollment monitor team.
Follow patients through study participation using electronic medical record review to ensure protocol compliance.
Enter study data in accordance with protocol, institutional, and regulatory requirements.
Monitor and report adverse events and deviations as required by sponsors, the institution, and federal regulations.
Maintain research charts or electronic files and ensure adequate source documentation for reported data.
Resolve sponsor-issued data queries and obtain and communicate protocol clarifications.
Schedule and prepare for sponsor monitoring visits; participate in monitoring visits and file related correspondence.
Facilitate requests and shipment of archival pathology samples.
Organize and prepare for internal and external audits.
Communicate with the clinical team about study patients and progress across multiple studies.
Maintain and organize study-specific regulatory binders.
Prepare and submit protocol amendments, continuing reviews, safety reports, and Data and Safety Monitoring Reports.
Revise informed consent documents to incorporate new risk information or updated protocol requirements.
Manage adverse-event and deviation, violation, or exception documentation and report it to sponsors and the IRB as required.
Maintain source documentation of correspondence with the IRB, investigators, and sponsors.
Collect, complete, and submit essential regulatory documents to regulatory entities.
Ensure appropriate documentation of delegation and training for study staff.
Maintain screening and enrollment logs.