Clinical Research Associate
Clinical Research Associate
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Job Description
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
The Cancer Center Protocol Office is seeking motivated detail-oriented individuals to join our team as a Clinical Research Associate. The Cancer Center Protocol Office is a centralized research office that supports clinical researchers in all disciplines within the Cancer Center. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.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
Qualifications
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 the 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
Facilitate the request and shipment of archival pathology samples
Organize and prepare for internal and external audits
Maintain ongoing communication with the 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
Additional Job Details (if applicable)
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
Education:
BA/BS degree required
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
EEO Statement:
Mass General Brigham Competency Framework
At Mass General Brigham our competency framework defines what effective leadership looks like by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance make hiring decisions identify development needs mobilize employees across our system and establish a strong talent pipeline.
Required Experience:
IC
Employment Type
Full-Time
