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Regulatory Coordinator I (Remote)
Job Description
Please note for this role, you will need to confirm your eligibility to work and reside in one of the following states: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, or Georgia.
The Regulatory Coordinator I prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, Third Party IRB (WIRB) and any research committee involved in the Pre-Award/Post-award process. This role submits continuations, amendments, responds to questions, generates reports, and maintains files, research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Research Department when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to insure all regulatory documents and requirements are up-to-date. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
- Prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS (if needed), Cedars-Sinai IRB, Third Party IRB (WIRB) and any research committee involved in the Pre-Award/Post-award process.
- Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
- Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
- Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
- Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date .
- Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
Qualifications
Please note for this role, you will need to confirm your eligibility to work and reside in one of the following states: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, or Georgia.
Required:
- Bachelors Degree
- At least 1 year in a regulatory coordination/clinical trial documentation role or directly related experience.
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Diversity and Inclusion at Cedars-Sinai
We are caretakers and innovators committed to the pursuit of equitable healthcare. But health equity is not possible without representation. Our commitment to diversity goes beyond demographics or checking boxes. Our people must reflect the diverse identities, experiences and geographies of the communities and patients we serve – because that’s what our patients, colleagues and communities deserve Quality Care and Research—For All, By All.
Our compensation philosophy
We offer a competitive compensation package for our employees. The base pay range shown generally applies to the greater Los Angeles area and may vary based on work location. Our range takes into account the wide range of factors that are considered in making compensation decisions, including knowledge/skills: relevant experience and training, education/certifications/licensure; and other business and organizational factors. The base pay range does not include any incentive payments that may be applicable to a role. Pay Transparency Non-Discrimination Provision (PDF) .
Cedars-Sinai is an Equal Employment Opportunity employer.
Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.
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