UC Irvine
Assistant Regulatory Affairs Coordinator
UC Irvine, California, Missouri, United States, 65018
Assistant Regulatory Affairs Coordinator
Join the Alpha Stem Cell Clinic (ASCC) at UC Irvine, a leader in regenerative medicine and clinical research. This role reports to the Assistant Director of Clinical Research Operations and works closely with the lead Regulatory Affairs Coordinator to manage regulatory aspects of clinical studies.
Responsibilities
Prepare and gather study‑related regulatory documents required by IRB, FDA, study sponsor, CRO, and Principal Investigator.
Maintain study regulatory binders and ensure all documents are filed and up‑to‑date in OnCore.
Organize and oversee study‑related meetings with sponsors and internal staff; schedule, send invites, take notes, and track follow‑up items.
Provide backup support for the lead regulatory coordinator and keep studies on schedule.
Ensure strict patient confidentiality in line with HIPAA regulations.
Assist with regulatory projects and participate in required training (HIPAA, GCP, etc.).
Qualifications
Bachelor’s degree with 1‑3 years of experience in regulatory or clinical research, or equivalent.
Excellent communication and organizational skills; strong written and verbal communication.
Proficiency with Microsoft Word, Excel, and data/file management.
Ability to multitask, prioritize workload, and meet deadlines in a dynamic environment.
High integrity, discretion, and proven confidentiality.
Strong problem‑solving and critical‑thinking abilities; initiative and teamwork.
Valid driver’s license and reliable transportation to off‑site research locations.
Preferred
Experience in regulatory affairs within academic research or clinical trials.
Commitment to ongoing change management and flexibility.
Compensation & Benefits Competitive salary range $83,000‑$120,000/year, plus comprehensive benefits including medical, dental, vision, retirement plans, paid leave, and employee discounts. Learn more about our benefits.
Conditions of Employment Applicants must undergo background check, work eligibility verification, and comply with university policies including vaccination, drug‑free environment, and misconduct disclosures.
Equal Opportunity Employment The University of California is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, veteran status, or any other protected category. Reasonable accommodations are provided for applicants with disabilities.
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Responsibilities
Prepare and gather study‑related regulatory documents required by IRB, FDA, study sponsor, CRO, and Principal Investigator.
Maintain study regulatory binders and ensure all documents are filed and up‑to‑date in OnCore.
Organize and oversee study‑related meetings with sponsors and internal staff; schedule, send invites, take notes, and track follow‑up items.
Provide backup support for the lead regulatory coordinator and keep studies on schedule.
Ensure strict patient confidentiality in line with HIPAA regulations.
Assist with regulatory projects and participate in required training (HIPAA, GCP, etc.).
Qualifications
Bachelor’s degree with 1‑3 years of experience in regulatory or clinical research, or equivalent.
Excellent communication and organizational skills; strong written and verbal communication.
Proficiency with Microsoft Word, Excel, and data/file management.
Ability to multitask, prioritize workload, and meet deadlines in a dynamic environment.
High integrity, discretion, and proven confidentiality.
Strong problem‑solving and critical‑thinking abilities; initiative and teamwork.
Valid driver’s license and reliable transportation to off‑site research locations.
Preferred
Experience in regulatory affairs within academic research or clinical trials.
Commitment to ongoing change management and flexibility.
Compensation & Benefits Competitive salary range $83,000‑$120,000/year, plus comprehensive benefits including medical, dental, vision, retirement plans, paid leave, and employee discounts. Learn more about our benefits.
Conditions of Employment Applicants must undergo background check, work eligibility verification, and comply with university policies including vaccination, drug‑free environment, and misconduct disclosures.
Equal Opportunity Employment The University of California is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, veteran status, or any other protected category. Reasonable accommodations are provided for applicants with disabilities.
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