What are the responsibilities and job description for the Regulatory Affairs Coord PD position at MemorialCare Shared Services?
Title: Regulatory Affairs Coord PD
Location: Fountain Valley
Department: Research Admin
Status: Per Diem
Shift: Days
Pay Range*: $38.00/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 Per-Diem regulatory affairs coordinator will work on reports necessary for FDA submissions, submissions to the IRB, study start up, regulatory filing and communication with the research team on an as needed basis.
This position collaborates with various departments across all MemorialCare Health system locations. They will work directly with Manager of Regulatory Affairs to ensure regulatory documents are prepared and submitted in accordance with FDA regulations, MemorialCare policies/procedures, relevant IRB policies and good clinical practices.
Essential Functions and Responsibilities of the Job
1. Work with regulatory affairs manager and/or 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. Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies.
5. Submit annual reports and updates as required.
6. Other duties as needed.
7. Ability to be at work and be on time.
8. Ability to follow company policies, procedures and directives.
9. Ability to interact in a positive and constructive manner.
10. Ability to 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:
Qualifications/Work Experience:
- Minimum of one (1) year of experience in the field of regulatory documentation management or
- clinical research required.
- Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) including Tracked
Changes functionality required.
- Excellent interpersonal and communication skills required.
- Experience submitting IRB applications (initial submissions and amendments) preferred.
- Knowledge of clinical trial federal, state and local regulations preferred
Education/Licensure/Certification:
Salary : $38
