Regulatory Research Coordinator, Clinical Trials

Arizona International; Tucson (AZ); On-site; USD 53,000 - 66,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid vacation

Sick leave

Holidays

Tuition reduction

State retirement plan

Recreation access

Job summary

University of Arizona is seeking a Regulatory Research Coordinator to manage regulatory and administrative tasks for clinical studies, ensuring compliance with GCP, FDA, HIPAA, and local IRB requirements. You will prepare submissions, maintain files, and support approvals and audits.

Join the Sarver Heart Center Clinical Research team to maintain study documents, track approvals, and assist with SOPs and regulatory workflows in a busy research environment.

Qualifications

• Minimum of 3 years of relevant work experience, or equivalent combination of education and work experience.
• Bachelor's degree or equivalent advanced learning attained through professional level experience required.

Responsibilities

• Preparation and submission of regulatory/IRB documents for sponsored and non-sponsored studies.
• Maintain regulatory investigator site files and essential study documents.
• Preparation and submission of applications for institutional approvals including relevant safety and biosafety committees.
• Provide regulatory support for site initiation visits, monitoring visits, quality audits and close-out.
• Assist with updating and drafting department SOPs, study procedure manuals and regulatory workflows.

Skills

Regulatory knowledge

FDA regulations

GCP compliance

CTMS experience

IRB systems

Education

Bachelor's degree

Tools

Oncore

Job description

University of Arizona is seeking a Regulatory Research Coordinator to manage regulatory and administrative tasks for clinical studies, ensuring compliance with GCP, FDA, HIPAA, and local IRB requirements. You will prepare submissions, maintain files, and support approvals and audits.

Join the Sarver Heart Center Clinical Research team to maintain study documents, track approvals, and assist with SOPs and regulatory workflows in a busy research environment.