Regulatory Affairs Coord I

Title: Regulatory Affairs Coord I

Location: Fountain Valley

Department: Research Admin

Status: Full-Time

Shift: Days

Pay Range*: $31.25/hr - $45.32/hr 

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 will assist the clinical study team(s) with the administration and regulatory compliance of clinical research. Responsibilities will include regulatory preparation, maintenance and 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.Assure all site documents, including SOPs and administrative files, are maintained in audit-ready condition.

3.Remain informed of current federal, state, and local regulations regarding clinical research and communicate any changes to study team.

4.Be at work and be on time.

5.Follow company policies, procedures and directives.

6.Interact in a positive and constructive manner.

7.Prioritize and multitask.

*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 MemorialCare—that 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.

Qualifications/Work Experience:

• Minimum of one (1) year of experience in the field of regulatory documentation management or clinical research required.
• Experience submitting IRB applications (new and amendments) preferred.
• Knowledge of clinical trial federal, state and local regulations preferred.
• Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) including Tracked Changes functionality required.
• Excellent interpersonal and communication skills required.

Education/Licensure/Certification:

• Associates degree or equivalent education required.
• Bachelor’s degree in relevant field preferred.
• Research certification (e.g. RAPS, ACRP, SoCRA or equivalent) preferred.
• Current CITI training certification preferred.