Talent.com
MemorialCare
Regulatory Affairs Coord I MemorialCare Shared Services Fountain Valley, CA LVNMemorialCare • Fountain Valley, CA, United States
No longer accepting applications
Regulatory Affairs Coord I MemorialCare Shared Services Fountain Valley, CA LVN

Regulatory Affairs Coord I MemorialCare Shared Services Fountain Valley, CA LVN

MemorialCare • Fountain Valley, CA, United States
11 days ago
Job type
  • Full-time
Job description

Regulatory Affairs Coordinator I

Location: Fountain Valley, CA

MemorialCare is a nonprofit integrated health system that includes four leading hospitals, award-winning medical groups consisting of over 200 sites of care, and more than 2,000 physicians throughout Orange and Los Angeles Counties. We are committed to increasing access to patient-centric, affordable, and high-quality healthcare; your personal contributions are integral to MemorialCare's recognition as a market leader and innovator in value-based and other care models.

Across our family of medical centers, we support each one of our bright, talented employees in reaching the highest levels of professional development, contribution, collaboration, and accountability. Whatever your role and whatever expertise you bring, we are dedicated to helping you achieve your full potential in an environment of respect, innovation, and teamwork.

Position Summary

The Regulatory Affairs Coordinator I (RAC I) supports clinical study team(s) with the administration and regulatory compliance of clinical research activities. Responsibilities will include regulatory preparation, maintenance and ongoing support for MemorialCare clinical research protocols. Projects may include industry-sponsored, federally-funded, and/or investigator-initiated studies.

Essential Functions and Responsibilities of the Job

  1. Work with principal investigator(s) to develop, draft, and compile research protocol documents and all materials required for regulatory submissions in compliance with Food and Drug Administration (FDA) and local Institutional Review Board (IRB) policies.
  2. For investigator initiated studies, assist the Principal Investigator (PI) and study team with the preparation, organization, submission support, tracking, and maintenance of applicable Food and Drug Administration (FDA) documents and correspondence, in compliance with FDA regulations, local Institutional Review Board (IRB) policies, and institutional requirements.
  3. Assure all site documents, including SOPs and administrative files, are maintained in audit-ready condition in accordance with applicable regulatory and institutional standards.
  4. Support initial, amendment, continuing review, and study closeout submissions as assigned, in accordance with applicable federal, state, local, and institutional requirements.
  5. Remain informed of current federal, state, and local regulations related to clinical research and communicate relevant updates to the study team as appropriate.
  6. Adhere to MemorialCare policies, procedures, and departmental guidelines, including those related to work schedules, hybrid and remote work arrangements, attendance, and regulatory operations.
  7. Interact in a positive, professional, and constructive manner with investigators, study staff, sponsors, IRBs, and internal stakeholders.
  8. Organize and prioritize assigned work and manage multiple tasks in support of clinical research regulatory activities.

*Placement in the pay range is based on multiple factors including, but not limited to, relevant years of experience and qualifications. In addition to base pay, there may be additional compensation available for this role, including but not limited to, shift differentials, extra shift incentives, and bonus opportunities. Health and wellness is our passion at MemorialCarethat includes taking good care of employees and their dependents. We offer high quality health insurance plan options, so you can select the best choice for your family. And there's more... Check out our MemorialCare Benefits for more information about our Benefits and Rewards.

Create a job alert for this search

Regulatory Affairs Coord I MemorialCare Shared Services Fountain Valley, CA LVN • Fountain Valley, CA, United States

Similar jobs

Regulatory Affairs Senior Advisor

Southern California EdisonRosemead, CA, United States
Full-time

Join the Clean Energy Revolutionu00a0Become a Regulatory Affairs Senior Advisor at Southern California Edison (SCE) and build a better tomorrow.In this job, you will be part of the State Regulatory... Show more

 • Promoted

Referral Clinical Coordinator

OneLegacyAzusa, CA, United States
Full-time

Join Us in Transforming Lives Every Day.At OneLegacy, every moment counts.As the nation's largest organ, eye, and tissue recovery organization, we are dedicated to saving lives and sharing hope.Gui... Show more

 • Promoted

Physical Therapist in Orange County

AltaMedAnaheim, CA, United States
Permanent

If you are as passionate about helping those in need as you are about growing your career, consider AltaMed.At AltaMed, your passion for helping others isn't just welcomed it's nurtured, celebrated... Show more

 • Promoted

RN II

AHMC Healthcare Inc.Whittier, CA, United States
Full-time

The Registered Nurse provides care, treatment, counseling and health education to the hospitalized patient.The RN is responsible for planning and coordination of care across the continuum.This plan... Show more

 • Promoted

RN Director of Nursing |Newport Coast Surgical Institute

SCA HealthNewport Coast, CA, United States
Full-time

At SCA Health, we believe health care is about people the patients we serve, the physicians we support and the teammates who push us forward.Behind every successful facility, procedure or innovati... Show more

 • Promoted

RN - CLINICAL DOCUMENTATION IMPROVEMENT MANAGER

Registry Ally, Inc.Orange, CA, United States
Full-time +1

Clinical Documentation Improvement Manager.Job Details RN - Clinical Documentation Improvement Manager for an academic health system in Orange, CA On-site for the first 6 months then Hybrid afterwa... Show more

 • Promoted

ASC Accreditation & Compliance Specialist LA/OC/IE/SD

Acuity Eye GroupSanta Ana, CA, United States
Full-time

ASC Accreditation & Compliance Specialist.The ASC Accreditation & Compliance Specialist is Acuity Eye Group's centralized subject matter expert for ambulatory surgery center accreditation and regul... Show more

 • Promoted

Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs

Dendreon PharmaceuticalsSeal Beach, CA, United States
Full-time

Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs.Seal Beach, California, United States.At Dendreon, we're transforming the battle against cancer with personalized immunothe... Show more

 • Promoted

Regulatory Affairs Manager

HuisongSanta Ana, CA, United States
Part-time

Regulatory Affairs Manager to support regulatory strategy and compliance for dietary supplements, botanical ingredients, herbal extracts, and Traditional Chinese Medicine products.The Regulatory Af... Show more

 • Promoted

Regulatory Affairs Manager

Huisong PharmaceuticalsSanta Ana, CA, United States
Part-time

About the JobRegulatory Affairs ManagerSanta Ana, CAPart-time EmployeeSalary depending on experience.About Huisong:Founded in 1998, Huisong Pharmaceuticals specializes in the R&D and manufactur... Show more

 • Promoted

Assistant Director, Clinical Research Business Operations

UC IrvineOrange, CA, United States
Full-time

Assistant Director For Clinical Research Business Operations.Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 p... Show more

 • Promoted

Director, Critical Care Services

AHMC Healthcare Inc.Anaheim, CA, United States
Full-time

The Director, ICU is accountable for the strategic planning, direction, organization and control of the inpatient Critical Care Services Department.This position is responsible for the direction of... Show more

 • Promoted

Regulatory Affairs Specialist

EnvistaBrea, CA, United States
Full-time

The Regulatory Affairs Specialist creates, evaluates and completes regulatory tasks related to worldwide product registration submissions, facility registrations, special projects and strategy to d... Show more

 • Promoted

Temporary Clinical Research Regulatory Coordinator

UC IrvineOrange, CA, United States
Part-time +1

UCI Temporary Employment Opportunity.Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.... Show more

 • Promoted

Critical Care RT/RCP - LA County

LifeLine Ambulance (CA)Los Alamitos, CA, United States
Full-time +1

Critical Care Rt/Rcp - La County.Commerce, CA 90040; Los Angeles, CA 90027; Los Alamitos, CA 90720.Hourly Level Experienced Position Type Full-Time/Part-Time Job Shift Any Category Health Care.Are ... Show more

 • Promoted

Regulatory Compliance Manager

DHD ConsultingBuena Park, CA, United States
Full-time

Buena Park, California, United States.About the Job Regulatory Compliance Manager.Provide regulatory leadership to cross-functional teams on existing and new regulations of FDA/USDA/CFIA labeling c... Show more

 • Promoted

Director, Lab Services - AMC - F/T - Days

UC IrvineOrange, CA, United States
Full-time

UCI Health is one of California's largest academic health systems and the clinical enterprise of the University of California, Irvine.Established on July 1, 1976, UCI Health has grown into a 1,461-... Show more

 • Promoted

Transplant Coordinator II - RN (Critical Care/ICU/ER RN's Required!)

OneLegacyAzusa, CA, United States
Full-time

Join Us in Transforming Lives Every Day.At OneLegacy, every moment counts.As the nation's largest organ, eye, and tissue recovery organization, we are dedicated to saving lives and sharing hope.Gui... Show more

 • Promoted

Senior Manager, Regulatory Strategy

Identified Talent SolutionsAzusa, CA, United States
Full-time

Senior Manager, Regulatory Strategy.Exciting opportunity to join a dynamic and innovative Cosmetics company - the team is committed to excellence and continuous improvement in all aspects of the bu... Show more

 • Promoted

System Director, Admissions and ED Registration - F/T - Days

UC IrvineOrange, CA, United States
Full-time

System Director, Admissions & ED Registration.UCI Health is one of California's largest academic health systems and the clinical enterprise of the University of California, Irvine.Established on Ju... Show more