Regulatory Affairs Coordinator - Cancer Center Protocol Office

General Summary:

The Regulatory Affairs Coordinator (RAC) will work with investigators, sponsors, Institutional Review Boards (IRB) and research support staff 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 and MGB hospitals to ensure regulatory compliance for multiple trials. This new position was specifically created to have a member of our team dedicated to helping persons with all of the above who are outside of teams we fully support. This team member will be trained on all processes that we perform, but instead of handling a standard study workload within our department, will be supporting anyone needing assistance with IRB submissions across MGH and our partner hospitals.

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 document

- 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.

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

- Being the point person for individuals outside of our department seeking support with the above items

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.

Qualifications

Qualifications

- BA/BS required

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

- Strong organizational skills

- Excellent oral and written communication skill

- Motivated to provide assistance to people in many different roles and in many cases be the face of our group to those unfamiliar with our processes

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

Candidates with no relevant experience will be hired as RAC I

EEO Statement

Massachusetts General Hospital 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.