Contract Clinical Research Regulatory Specialist

University of California, Irvine; Orange (CA); On-site; USD 44,083 - 63,369; Full time

Job summary

University of California, Irvine seeks a Regulatory Affairs professional to independently manage the regulatory lifecycle of clinical studies, including activation, submissions, amendments, and closeout. You will prepare and oversee all regulatory documents and collaborate with investigators, sponsors, and regulators to maintain compliance.

Ideal candidates have 3–5 years regulatory experience, knowledge of FDA/GCP/IRB processes, and proficiency with OnCore or Complion in a healthcare research

Qualifications

• Bachelor's degree or equivalent in a related field.
• 3–5 years of regulatory experience for clinical research.
• Knowledge of FDA, GCP, IRB processes for Phase I–III trials.
• Ability to read/write English and manage multiple projects.

Responsibilities

• Independently manage regulatory lifecycle of clinical studies (activation, submissions, amendments, SAEs, closeout).
• Prepare and oversee regulatory documents (informed consent, HIPAA, files, electronic binders).
• Collaborate with investigators, sponsors, and regulators to resolve issues and ensure compliance.
• Lead readiness for sponsor visits, audits, and inspections with audit-ready documentation.

Skills

Regulatory management

FDA regulations

GCP

IRB processes

Project management

Education

Bachelor's degree in related field

Tools

OnCore

Complion

Job description

University of California, Irvine seeks a Regulatory Affairs professional to independently manage the regulatory lifecycle of clinical studies, including activation, submissions, amendments, and closeout. You will prepare and oversee all regulatory documents and collaborate with investigators, sponsors, and regulators to maintain compliance.

Ideal candidates have 3–5 years regulatory experience, knowledge of FDA/GCP/IRB processes, and proficiency with OnCore or Complion in a healthcare research