Regulatory Affairs 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 Regulatory Affairs Coordinator (RAC) will work with investigators, study staff, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies to ensure that regulatory requirements are met for clinical trials. This role reports to the Regulatory Affairs Project/Program Manager and works closely with research teams across the Cancer Center to ensure regulatory compliance for multiple cancer trials.



Qualifications


Detailed Responsibilities include managing the following for multiple studies:


- Preparation and submission of clinical trials to the local and central IRB(s).


- Creation and extensive revisions of informed consent documents


- Tracking and facilitating the progress of new trials through the review process


- Correspondence with the IRB of record, investigators, and sponsors throughout the review process


- Collection, completion, and submission of regulatory documents to various regulatory entities. This includes collecting signatures and information from participating investigators and providing them to industry sponsors.


- Creation and maintenance of electronic regulatory binders and other relevant files during the approval process


- In addition to the above, this role will be submitting institution-sponsored studies to the FDA and maintaining the records with the FDA across the life of the study. This includes sending annual reports to the FDA for dozens of studies, as well as communicating with the FDA about changes to studies and any adverse events that may occur.


Please note that this is a remote role and there will be no work at the physical office/location. Applicants may work in all states with the following exceptions: WY, ND, Puerto Rico, and the U.S. Virgin Islands.



Additional Job Details (if applicable)


- BA/BS required


- Prior regulatory or clinical research experience with an academic medical center or industry preferred


- Knowledge of FDA submission process a plus


- Detail-orientation with the ability to manage multiple projects simultaneously


- Strong organizational skills


- Excellent oral and written communication skills


Candidates with no relevant experience will be hired as RAC I



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.