CR Regulatory Coordinator Location:

Ogden, UT - Onsite Our client, a respected clinical research organization, seeks a CR Regulatory Coordinator to join their regulatory affairs team on-site. Do you love keeping complex projects organized and compliant down to the smallest detail? Does the idea of being the go-to person who keeps clinical studies moving smoothly through IRB approvals excite you? If you answered yes, this could be the perfect CR Regulatory Coordinator role for you. Keep scrolling to see what this company has to offer. The Perks!

Compensation:

$20.00 - $25.00/hourly, based on experience + quarterly bonuses based on site performance 401k + 3% employer matching Health insurance, employer pays 20% of the employee's premium Paid Time Off FSA A Day in the Life of a

CR Regulatory Coordinator:

In this role, you'll be the backbone of regulatory compliance for clinical studies, preparing and submitting documentation to the IRB while making sure every study stays aligned with federal and site-specific requirements. You'll work closely with the Principal Investigator and study team, keeping regulatory binders and electronic systems accurate and audit-ready. Your work directly supports the organization's mission by helping studies launch, run, and close out without compliance hiccups.

Responsibilities include:

Preparing, facilitating, submitting, and maintaining IRB applications for study start-up, protocol revisions, amendments, administrative changes, and more Completing, auditing, and maintaining study records and databases to ensure compliance with study protocols, FDA, IRB, and site SOPs Preparing regulatory documents and securing signatures for FDA 1572s, Financial Disclosure Forms, Protocol Signature Pages, IB Acknowledgment of Receipts, Delegation Logs, and training documents Filing correspondence and key documents in electronic regulatory systems and paper-based regulatory binders Communicating with research staff, sponsors, and project teams to ensure accuracy of regulatory documents and submissions Tracking study approvals and expirations to prevent lapses in project approval Submitting study renewal applications and progress reports to the IRB Coordinating with sponsors, investigators, and the IRB across the full study lifecycle, from start-up to closure Guiding investigators and research staff on regulatory process and policy questions Recommending and implementing improvements to regulatory processes Staying current on federal and institutional research guidelines

Requirements and Qualifications:

1+ year of clinical research experience Prior experience supporting a Principal Investigator or study team directly Solid experience preparing or submitting regulatory documents (e.g., IRB submissions, FDA 1572s, financial disclosure forms, delegation logs) Experience using Veeva Site Vault or a similar electronic regulatory system CCRP certification preferred Experience handling safety or protocol deviation reporting to an IRB Strong organizational skills and meticulous attention to detail Comfort working with both electronic regulatory systems and paper-based filing A proactive, team-oriented attitude with genuine enthusiasm for supporting clinical research About the

Hiring Company:

Our client is a clinical research organization dedicated to advancing medical knowledge through well-run, participant-focused clinical trials. They value clinical excellence, integrity, and collaboration among their research staff. Come Join Our Regulatory Affairs Team! Start by filling out this 3-minute, mobile-friendly application here. We look forward to hearing from you! #ADM123

Pay:

$20.00 - $25.00 per hour

Benefits:

401(k) 401(k) matching Flexible spending account Health insurance Application Question(s): On a scale from 1-10, how confident are you in the quality of your work?

Experience:

clinical research : 1 year (Required) supporting a Principal Investigator or study team directly: 1 year (Required) reparing or submitting regulatory documents: 1 year (Required) Veeva Site Vault or a similar electronic regulatory system: 1 year (Required) handling safety or protocol deviation reporting to an

IRB:

1 year (Required) Ability to

Commute:

Ogden, UT 84244 (Required)

Work Location:

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