Sr. Regulatory Coordinator - LosAngeles, United States - Cedars Sinai Medical Center

Description

Grow your career at Cedars-Sinai

The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all of our patients with cancer

Join our team and contribute to groundbreaking research

Job Summary:
Prepares and submits moderately complex protocols and supporting documentation to regulatory bodies and research committees involved in the pre-award and post-award process. This role submits the continuations, amendments to regulatory bodies and responds to a broad range of questions. Generates reports and maintains files and documentation for compliance with regulatory requirements (federal and local agencies, including the Food and Drug Administration and Local Institutional Review Board) for the assigned study and/or clinical trial.
Primary Duties and Responsibilities

• Submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices.

• Completes forms and generates reports from multiple data sources to comply with the assigned protocals for the study and/or clinical trail.

• Maintains research files and may audit documentation pertaining to regulatory requirements for clinical trails.

• Responds to generally broad data requests and questions.

• Monitors the status of assigned regulatory submissions and amendments from end-to-end.

• Partners with research staff and investigators to ensure that all regulatory documents for the assigned research studies are up to date.

• Represents the unit in cross functional meetings and provides updates on the status of assigned regulatory submissions.

• Supports the unit in internal and external auditing of regulatory documents.

• Identifies quality and performance improvement opportunities to support efficient workflows.

• Maintains strict patient confidentiality according to HIPAA regulations and follows guidance according to applicable law, research practices using Good Clinical Practice (GCP) guidelines.

Qualifications:

• Bachelor's Degree Required
• 3 years relative experience in a research related field required
• Certification In Clinical Research (CCRP) preferred

Physical Demands:

Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.
Perform continuous operation of a personal computer for four hours or more.
Use hands and fingers to handle and manipulate objects and/or operate equipment.

Working Title:

Sr. Regulatory Coordinator -The Angeles Clinic & Research Institute

Department:

Angeles Research

Business Entity:

Cedars-Sinai Medical Care Foundation

Job Category:

Compliance/Quality

Job Specialty:

Research Compliance

Position Type:

Full-time

Shift Length:

8 hour shift

Shift Type:

Day

Base Pay:

$29.95 – $46.42

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 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. Cedars-Sinai's AA Policy Statement (PDF) (opens in new window)

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