Sr. Regulatory Coordinator

4 weeks ago

Santa Monica, United States Cedars-Sinai Full time

**Job 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**

**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.

**About Us**

Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.

**About the Team**

With a growing number of primary urgent and specialty care locations across Southern California, Cedars-Sinais medical network serves people near where they live. Delivering coordinated, compassionate healthcare you can join our network of clinicians and physicians to improve the healthcare people throughout Los Angeles and beyond.

**Req ID**

: HRC1441303

**Working Title**

: Sr. Regulatory Coordinator -The Angeles Clinic & Research Institute

**Department**

: Angeles Research Inst

**Business Entity**

: Cedars-Sinai Medical Care Foundation

**Job Category**

: Compliance / Quality

**Job Specialty**

: Research Compliance

**Overtime Status**

: NONEXEMPT

**Primary Shift**

: Day

**Shift Duration**

: 8 hour

**Base Pay**

: $29.95 - $46.42 Cedars-Sinai is an EEO 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.

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