Title: Regulatory Affairs Coordinator I

Location: Fountain Valley, CA

Department: Research Administration

Status: Full-time

Shift: Day

Pay Range*: $32.19/hr - $46.68/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

TheRegulatoryAffairsCoordinatorI(RACI)supportsclinicalstudyteam(s)withtheadministration 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 materialsrequiredforregulatorysubmissionsincompliancewithFoodandDrugAdministration(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 updatesto 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 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.

Minimum Requirements

Qualifications/Work Experience:

·         Minimum of one (1) year of experience in the field of regulatory documentation management or clinical research required.

·         Proficiency in Microsoft Office applications (Word, Excel, and Adobe Acrobat), including use of tracked changes and document version control, required.

·         Excellent interpersonal and communication skills required.

·         Experience submitting IRB applications (initial submissions and amendments) preferred.

·         Working knowledge of applicable  federal, state and local clinical research regulations preferred.

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.