Regulatory Clinical Research Coordinator - Sarver Heart Center

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

Job Information

• Posting Number: req26826
• Department: Sarver Heart Center
• Department Website Link: https://heart.arizona.edu
• Location: Tucson Campus
• Address: 1501 N. Campbell Ave., Tucson, AZ 85719 USA
• FLSA: Exempt
• Full Time/Part Time: Full Time
• Number of Hours Worked per Week: 40
• Job FTE: 1.0
• Work Calendar: Fiscal
• Job Category: Research
• Benefits Eligible: Yes - Full Benefits
• Rate of Pay: $53,039-$66,299
• Compensation Type: salary at 1.0 full-time equivalency (FTE)
• Grade: 7
• Compensation Guidance: The Rate of Pay Field represents the University of Arizona's good faith and reasonable estimate of the range of possible compensation at the time of posting. The University considers several factors when extending an offer, including but not limited to, the role and associated responsibilities, a candidate's work experience, education/training, key skills, and internal equity. The Grade Range represent a full range of career compensation growth over time. The university offers compensation growth opportunities within its career architecture. To learn more about compensation, please review our Applicant Compensation Guide and our Total Rewards Calculator.
• Career Stream and Level: PC2
• Job Family: Clinical Research
• Job Function: Research
• Type of criminal background check required: Name-based criminal background check (non-security sensitive)
• Number of Vacancies: 1
• Open Date: 8/17/2026
• Open Until Filled: Yes
• Documents Needed to Apply: Resume and Cover Letter

Position Highlights

The Regulatory Research Coordinator is responsible for coordinating the regulatory and administrative aspects of clinical research studies to ensure compliance with federal regulations, institutional policies, sponsor requirements, and Good Clinical Practice (GCP) guidelines. This role will support the Sarver Heart Center Clinical Research team by preparing and maintaining regulatory documentation, facilitating ethics and institutional approvals, and ensuring research compliance.

• Visa sponsorship is not available for this position.

• health, dental, and vision insurance plans
• life insurance and disability programs
• paid vacation, sick leave, and holidays
• UA/ASU/NAU tuition reduction for the employee and qualified family members
• state retirement plan
• access to UA recreation and cultural activities
• and more!

The University of Arizona has been recognized for our innovative work-life programs. For more information about working at the University of Arizona and relocation services, please click here.

Duties & Responsibilities

• Preparation and submission of regulatory/IRB documents for sponsored and non-sponsored studies including but not limited to local IRB deferrals; local IRB full submissions; central IRB submissions; amendments; annual renewals; regulatory reportable items; and study closures.
• Maintain regulatory investigator site files and essential study documents in accordance with sponsor and institutional requirements. This includes collection of investigator qualifications, training records, financial disclosures, and required certifications. Track study approvals, expiration dates, investigator credentials, and required training.
• Preparation and submission of applications for institutional approvals including Research Administration Portal, Radiation Safety and Institutional Biosafety Committee for sponsored and non-sponsored studies including amendments. Maintain records for all studies in Oncore.
• 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 as required.

Knowledge, Skills & Abilities

• Knowledge of FDA regulations, ICH-GCP, 45 CFR 46, HIPAA, and human subjects' protection requirements.
• Knowledge of electronic IRB systems and clinical trial management systems (CTMS).

This job posting reflects the general nature and level of work expected of the selected candidate(s). It is not intended to be an exhaustive list of all duties and responsibilities. The institution reserves the right to amend or update this description as organizational priorities and institutional needs evolve.

Minimum 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.

Preferred Qualifications

• Experience with drug or device clinical trials.

Notice of Availability of the Annual Security and Fire Safety Report

In compliance with the Jeanne Clery Campus Safety Act (Clery Act), each year the University of Arizona releases an Annual Security Report (ASR) for each of the University's campuses.Thesereports disclose information including Clery crime statistics for the previous three calendar years and policies, procedures, and programs the University uses to keep students and employees safe, including how to report crimes or other emergencies and resources for crime victims. As a campus with residential housing facilities, the Main Campus ASR also includes a combined Annual Fire Safety report with information on fire statistics and fire safety systems, policies, and procedures. Paper copies of the Reports can be obtained by contacting the University Compliance Office at [e-mail].

Contact Information for Candidates

Gerry Flores

[e-mail]