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Job Summary
The Regulatory Affairs Coordinator (RAC) will work with investigators, study staff, Institutional Review Boards (IRBs), 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.
Qualifications
Principal Responsibilities
The following duties will be performed independently:
Facilitate initial new trial submission for SRC and IRB reviewDevelop the Informed Consent document for the clinical trial protocol with the input of the trial’s sponsor and Principal InvestigatorCorrespondence with the IRB, investigators, and sponsors throughout the review processProvide clinical trial sponsors with required regulatory documents during study initiation processPrepare and submit protocol amendments during the IRB review processCreation and maintenance of electronic regulatory bindersMaintain a working knowledge of the IRB’s current guidelines and forms for protocol and consent form submissionsSpecialize in certain disease groups, which includes maintaining study staff listsPlease note that this is a remote role and there will be no 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)
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 a RAC I
Remote Type
Remote
Work Location
101 Merrimac Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
EEO Statement:
The General Hospital Corporation is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.
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