Clinical Research Regulatory Coordinator – Level II (Remote)

Job Description

Please note: Only candidates residing in the following states will be considered for remote work: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia.

The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in the Pre-Award/Post-award process. This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Research Department when meeting with sponsors, attending team meetings, and working with other staff to ensure all regulatory documents and requirements are met and up-to-date.

May plan and coordinate strategies for improving efficiency, action plans to improve quality, and training and education of personnel. 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, External IRB, IACUC and any research committee involved in Pre/Post-award
  process.
• Submits continuations and amendments as necessary to maintain compliance with regulatory requirements
  and institutional policies.
• Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
• 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 requirement for clinical trials.
• Meets with monitors from pharmaceutical companies and represents the Medical Center during these meetings.
• 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 research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
• Participates in required training and education programs and may provide training and education of other personnel.
• May participate in centralized activities of the department or institution.
• May plan and coordinate strategies to improve existing standard operating procedures related to regulatory Affairs including drafting SOP’s and/or job aids.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Ensures compliance with all federal and local agencies including the Food and Drug Administraton (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Qualifications

Please note: Only candidates residing in the following states will be considered for remote work: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia.

Required:

• Bachelor’s degree (BA or BS)
• Minimum of 3 years of directly related experience
• Preferred: Additional experience beyond the minimum is preferred

Diversity and Inclusion at Cedars-Sinai

Our compensation philosophy

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.