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Lead Compliance Coordinator for Research

2 months ago

Santa Monica, California, United States Cedars-Sinai Full time

Job Overview

Advance your career with Cedars-Sinai

The Angeles Clinic & Research Institute is renowned for its pioneering work in developing innovative cancer treatments, delivering both experimental and traditional care, and mentoring the next generation of healthcare professionals. Our team comprises board-certified oncologists, surgeons, immunotherapists, pathologists, and dermatologists who collaborate to enhance cancer treatment. We are dedicated to providing cutting-edge therapeutic options to all our cancer patients.

Become a part of our team and engage in transformative research

Position Summary:

This role involves preparing and submitting moderately complex protocols and associated documentation to regulatory agencies and research committees throughout the pre-award and post-award phases. Responsibilities include submitting continuations and amendments to regulatory bodies and addressing a wide range of inquiries. The position also entails generating reports and maintaining documentation to ensure compliance with regulatory standards (federal and local agencies, including the Food and Drug Administration and Local Institutional Review Board) for the designated study and/or clinical trial.

Key Responsibilities:

  • Submit continuations and amendments to maintain adherence to regulatory standards and institutional policies.
  • Complete forms and produce reports from various data sources to comply with the assigned protocols for the study and/or clinical trial.
  • Maintain research documentation and may conduct audits related to regulatory compliance for clinical trials.
  • Respond to broad data requests and inquiries.
  • Track the status of assigned regulatory submissions and amendments from start to finish.
  • Collaborate with research staff and investigators to ensure that all regulatory documents for the assigned research studies are current.
  • Represent the unit in cross-functional meetings and provide updates on the status of assigned regulatory submissions.
  • Assist the unit in internal and external audits of regulatory documents.
  • Identify opportunities for quality and performance improvements to enhance workflow efficiency.
  • Uphold strict patient confidentiality in accordance with HIPAA regulations and adhere to applicable laws and research practices using Good Clinical Practice (GCP) guidelines.

Qualifications:

Required:

  • Bachelor's Degree
  • 3 years of relevant experience in a research-related field
  • Certification in Clinical Research (CCRP) is preferred

Physical Requirements:

  • Ability to 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 extended periods.
  • Utilize hands and fingers to handle and manipulate objects and/or operate equipment.

About Cedars-Sinai:

Cedars-Sinai is a leader in delivering high-quality healthcare, encompassing primary care, specialized medicine, and research. Since its inception, Cedars-Sinai has adapted to meet the needs of one of the most diverse regions in the nation, setting benchmarks in quality and innovative patient care, research, education, and community service. Today, Cedars-Sinai is recognized for its national leadership in transforming healthcare for the benefit of patients, influencing the future of healthcare through the development of new treatment approaches and the education of tomorrow's health professionals. Furthermore, Cedars-Sinai is committed to the community through initiatives that enhance the health of its most vulnerable residents.

About the Team:

With an expanding network of primary urgent and specialty care locations across Southern California, Cedars-Sinai's medical network serves individuals close to their homes. By delivering coordinated and compassionate healthcare, you can join our network of clinicians and physicians to improve healthcare access for people throughout the region.

Job ID: HRC

Working Title: Senior Regulatory Coordinator - The Angeles Clinic & Research Institute

Department: Angeles Research Institute

Business Entity: Cedars-Sinai Medical Care Foundation

Job Category: Compliance / Quality

Job Specialty: Research Compliance

Overtime Status: Nonexempt

Primary Shift: Day

Shift Duration: 8 hours

Base Pay: $46.42

Cedars-Sinai is an equal opportunity employer and does not unlawfully discriminate based on race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical conditions, marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age, military or veteran status, or any other basis protected by federal or state law.