Clinical Research Associate 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.

 

 

Job Summary

General Summary/Overview Statement:

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.

Principal Duties and Responsibilities:
The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager:

· 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

The following regulatory duties may be performed under general supervision by the Clinical Research Manager:

· 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

Skills/Abilities/Competencies Required

· 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


Working Conditions:

· Duties may be performed in a combination of on-site and remote work setting.

 

Qualifications

Education
Bachelor's Degree Related Field of Study required

Can this role accept experience in lieu of a degree? No

Licenses and Credentials

Experience
Research Related Experience 1-2 years preferred

Knowledge, Skills and Abilities
- Attention to detail.
- Ability to recognize compliance and data integrity issues and respond appropriately.
- Knowledge of medical terminology.
- Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
- Effective interpersonal and communications skil