Regulatory Program Manager - Dermatology (College of Medicine - Tucson)

The Regulatory Program Manager will serve as the Dermatology department's primary resource for all regulatory and compliance-related matters in translational research and clinical trials. This position is responsible for preparing, submitting, and maintaining human subjects and clinical research protocols, continuing reviews, and amendments through the UA and Banner research compliance units, including the Human Subjects Protection Program (HSPP). The manager will ensure compliance with university, sponsor, HIPAA, and federal regulations; provide technical and regulatory guidance to investigators and staff; and facilitate collaboration between research teams, the HSPP office, and sponsors to maintain participant and data safety while advancing research goals. The manager will also provide dedicated strategic support for clinical research and trials and will work closely with clinical faculty, investigators, regulatory staff, clinical trials sponsors (e.g. private indistry and national cooperative groups) and administrative staff.

Outstanding U of A benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; U of A/ASU/NAU tuition reduction for the employee and qualified family members; retirement plans; access to U of A recreation and cultural activities; and more!

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Clinical Study Protocol Preparation and Submission

• Lead the preparation, review, and submission of translational and clinical research protocols and amendments, resolving complex regulatory or procedural issues to ensure successful UA IRB approval.
• Manage studies through all stages of the UA Institutional Review Board (IRB) process including continuing reviews, ensuring compliance with UA, Banner, and sponsor requirements.
• Draft and revise study materials, amendments, and human subjects sections for grant proposals. Help advise on resources necessary to conduct new and ongoing research protocols for preparing study budgets.
• Maintain accurate documentation for multiple departmental protocols and ensure timely renewals and updates.

Regulatory and Compliance Guidance

• Serve as the department's primary resource for regulatory and compliance-related questions.
• Advise faculty and staff on HSPP, IRB, university, and sponsor requirements, regulations, and policies, providing guidance on policy interpretation, and assisting in identifying compliant research strategies.
• Maintain and communicate up-to-date knowledge of legislation, rules, regulations, and policies, providing proactive guidance to physicians and staff to ensure consistent compliance and informed decision-making.
• Provide technical guidance on FDA regulations, including investigational new drug (IND) requirements when applicable.

Clinical Study and Participant Coordination

• Supervise day-to-day activities of the assigned Clinical Research Coordinators in the department, including prioritization and assignment of work; communication of expectations and standards; hiring, training, and performance evaluations.
• Provide guidance and oversight to Clinical Research Coordinators (CRCs) on protocol implementation and data collection issues, supporting effective trial recruitment, portfolio management, and trial startup and maintenance activities.
• Analyze and report study activation and progress metrics to PIs, providing insights and recommendations to enhance operational efficiency.
• Collaborate with investigators and regulatory offices to develop creative, compliant solutions to research challenges by developing and maintaining effective relationships with clinical research physicians, industry partners, and UA and Banner oversight offices. Assist in identifying and resolving compliance or procedural issues.

Data Management and Operational Oversight

• Monitor and evaluate program performance, including goals, deadlines, budgets, and expenditures, and recommend adjustments to improve efficiency, resource utilization, and overall program outcomes.
• Actively participate in research team meetings and proactively collaborate with Banner clinic staff to ensure patient safety and adherence to protocol requirements.
• Develop and/or maintain the clinical research databases, conduct data reviews, and process data queries.

Knowledge, Skills & Abilities:

• Problem-solving and adaptability to address technical and operational challenges efficiently.
• Collaboration and interpersonal skills to work effectively with a variety of partners, both internal and external.
• Knowledge of clinical research regulations.
• Regulatory and document management skills.
• Knowledge of clinical trial management system (e.g. OnCore) and clinical research databases (e.g. OpenSpecimen, RedCap)

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.

• Bachelor's degree or equivalent advanced learning attained through professional level experience required, and;
• Three (3) years of related work experience or equivalent combination of education and work experience required.

• Thorough understanding of HSPP requirements and UA and Banner IRB study approval processes and requirements.
• Master's Degree.
• Experience working with oncology trials, including Phase 1 trials.