Clinical Research Associate

Mass General Brigham•Boston, MA

1d•Hybrid

About The Position

The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact.

Requirements

Bachelor's Degree Related Field of Study required
1-2 years preferred Research Related Experience
Attention to detail.
Ability to recognize compliance and data integrity issues and respond appropriately.
Working knowledge of clinical research protocols.
Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
Effective interpersonal and communication skills.
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.

Responsibilities

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.
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.
Organize and prepare for internal and external audits.
Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies.