Clinical Research Associate

Site: The General Hospital Corporation

At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our missionfrom doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.

At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds to apply.

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 clinical research regulations. 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 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 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)

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

BA/BS degree required

Remote Type

Onsite

Work Location

101 Merrimac Street

EEO Statement:

The General Hospital Corporation is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. 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.