Regulatory Specialist

Department Overview

The UCSF Memory and Aging Center (MAC) is an internationally renowned clinical and translational research center with over 300 full time employees with offices and clinical research space located in the Sandler Neurosciences Building and multiple other buildings on the UCSF Mission Bay Campus. The MAC provides clinical care for patients suffering from neurodegenerative disorders.;

Our mission is to find effective and scientifically-based treatments that lead to a cure for neurodegenerative brain diseases. This is accomplished through clinical trials that emphasize patient and family benefits and public health impact, and observational studies that deepen our understanding of the biological mechanisms of neurodegenerative disease.

Job Summary

The Regulatory Specialist role involves managing or performing the administrative services or managing the full general operations of an academic or non-academic organization(s). Administrative services include activities in finance and human resources and may also include IT, facilities, or student services. General management activities include long and short range strategic planning in determining the mission and directing all activities of multi-disciplinary departments through subordinate management staff.

The Regulatory Specialist will use skills as a seasoned and experienced professional to oversee the regulatory operations of the Memory and Aging Center Clinical Trials Program and to contribute to the general administrative operations of the program. They will report to the Research Nurse Manager of the program and will work closely with program leadership and other team members to manage regulatory compliance for investigator-initiated and industry-sponsored clinical trials. This role ensures compliance with institutional, federal, and sponsor requirements by coordinating the preparation and submission of regulatory documents to IRBs, sponsors, and regulatory agencies. The regulatory specialist collaborates closely with principal investigators, study teams, study sponsors, and administrative offices to facilitate timely study activation and maintain ongoing regulatory compliance in a complex academic research environment. The ideal candidate is collaborative, will thrive in a fast-paced environment, possess exceptional organizational and communication skills, demonstrate good judgment in prioritizing multiple competing deadlines, and has a passion for contributing to impactful medical research.

Required Qualifications:

• Bachelor's degree
• 3+ years of related work experience; and / or equivalent experience / training.
• Interpersonal skills including verbal and written communication, active listening, critical thinking, persuasiveness, advising and counseling skills.
• Ability to use discretion and maintain confidentiality.
• Strong skills in short-term planning, analysis, problem-solving, and customer service.
• Clinical research with FDA regulated studies experience

• Experience with IRB preparation and management

Preferred Qualifications:

• Thorough knowledge of University rules and regulations, processes, protocols and procedures for budget, accounting and fund management, and / or personnel management.
• Knowledge of a variety of administrative operational activities such as event planning, basic fundraising processes, risk management planning, website design, accounting and payroll, and contracts and grants regulations and guidelines.
• Solid knowledge of common University-specific computer application programs.
• Clinical trials experience
• Project management experience
• Clinical Trials experience, including working with study budgets, contracts, start-up, and regulatory documentation
• Ability to prioritize when there are multiple competing deadlines
  

Required Qualifications:

• Bachelor's degree
• 3+ years of related work experience; and / or equivalent experience / training.
• Interpersonal skills including verbal and written communication, active listening, critical thinking, persuasiveness, advising and counseling skills.
• Ability to use discretion and maintain confidentiality.
• Strong skills in short-term planning, analysis, problem-solving, and customer service.
• Clinical research with FDA regulated studies experience

• Experience with IRB preparation and management

Preferred Qualifications:

• Thorough knowledge of University rules and regulations, processes, protocols and procedures for budget, accounting and fund management, and / or personnel management.
• Knowledge of a variety of administrative operational activities such as event planning, basic fundraising processes, risk management planning, website design, accounting and payroll, and contracts and grants regulations and guidelines.
• Solid knowledge of common University-specific computer application programs.
• Clinical trials experience
• Project management experience
• Clinical Trials experience, including working with study budgets, contracts, start-up, and regulatory documentation
• Ability to prioritize when there are multiple competing deadlines