Clinical Research Regulatory Coordinator at Partner's Healthcare in Boston, Massachusetts

Job Description:

Site: The General Hospital Corporation


At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from 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 Regulatory Coordinator. 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 Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.



Qualifications


PRINCIPAL DUTIES AND RESPONSIBILITIES:


The following regulatory duties will 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

Additional Job Details (if applicable)


EDUCATION:

• BA/BS degree required

Remote Type


Remote



Work Location


2014 Washington Street



Scheduled Weekly Hours


40



Employee Type


Regular



Work Shift


Day (United States of America)



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. Apply Now