Clinical Research Coordinator II
 Massachusetts General Hospital | |
 United States, Massachusetts, Boston | |
| 101 Merrimac Street (Show on map) | |
 Mar 07, 2025 | |
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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 Research Manager and works closely with research teams across the Cancer Center to ensure regulatory compliance for multiple cancer trials.
Detailed Responsibilities include managing the following for multiple studies: - Preparation and submission of clinical trials to the IRB. - Creation and extensive revisions of informed consent documents - Tracking and facilitating the progress of new trials through the review process - Correspondence with the IRB, 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 across the life of a study - Completion and submission of clinical trials amendments to the IRB. This includes large amendments to the Protocol and other study documents received from industry sponsors throughout the course of the study, as well as smaller amendments to keep documents and processes up-to-date - Preparation of annual progress reports for IRB renewal of ongoing studies 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 - BA/BS required - Detail-orientation with the ability to manage multiple projects simultaneously - Strong organizational skills - Excellent oral and written communication skills - Prior regulatory or clinical research experience with an academic medical center or industry a plus Candidates with no relevant experience will be hired as RAC I The General Hospital Corporation is an Equal Opportunity 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. | |