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Regulatory Coordinator II - Remote Position, Cancer Clinical Trials

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Requisition # HRC1095784

Job Summary:
The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory
bodies such as PRMC, IRB, and IACUC. 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 Medical Center when
meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to
insure 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 Job Responsibilities
• Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and
• IACUC.
• 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 requirements 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 weekly research team meetings and updates staff and investigators on the status of regulatory
• submission and amendments.
• 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.
• 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 Administration (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.
• Participates in required training and education programs.


Educational Requirements:

Bachelor's Degree BA/BS degree.

Licenses:

Cert Clin Research Professional Specialty research certification preferred. Upon Hire

Experience:

Three (3) years minimum research related experience.

Physical Demands:

Able to perform moderate lifting.  Able to sit, stand and walk for prolonged periods of time.  Able to read papers and online documents.  Able to operate standard office equipment.  Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.


Working Title: Regulatory Coordinator II - Remote Position, Cancer Clinical Trials
Department: SOCCI Clinical Research Office
Business Entity: Academic / Research
Job Category: Compliance/Quality
Job Specialty: Research Compliance
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day

Base Pay: $64,800.00 - $110,000.00

Our compensation philosophy

We offer competitive total compensation that includes pay, benefits, and other recognition programs for our employees. The base pay range shown above 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. This base pay range does not include our comprehensive benefits package and any incentive payments that may be applicable to this role

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.

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) and COVID-19. 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 such as COVID-19 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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