Regulatory Specialist

The Masonic Cancer Center’s Clinical Trials Office is committed to an excellent employee experience, offering a flexible work environment that meets the needs of students, staff, faculty, and the communities we serve. Flexible work arrangements may include flexibility in schedule and/or work location. All UMN employees are expected to follow applicable public health and safety procedures. This position is remote with infrequent in-person team functions.

JOB RESPONSIBILITIES

Regulatory Management of Clinical Studies (80%)

Provides regulatory guidance and direction to research team members to ensure compliance with all applicable policies, procedures and regulations.

Serves as primary contact for purposes of collection, organization, completion, and retention of essential regulatory documentation.

Collaborates with the Principal Investigator, study coordinators, and other research team members to interpret protocols and edit consent documents as needed for clinical research studies.

Prepares FDA, IRB, and other required reviewer’s applications, respond to stipulations, and shepherd applications by coordinating communications and documentation through the processes until approvals are obtained.

Tracks all regulatory review submissions and approvals to ensure deadlines are met.

Maintains investigator site binder (essential regulatory documents) to ensure ongoing compliance and audit-readiness.

Reviews outside safety reports and local serious adverse events and assesses for regulatory reporting. Identifies and reports unanticipated problems involving risk to subjects or others (UPIRTSO) within the required timeline.

Prepares for and participates in sponsor/CRO interactions and monitoring visits, which may include prequalification, site initiation, interim monitoring, and closeout visits.

Serves as the regulatory subject matter expert through all phases of a clinical study.

Provides input during protocol development activities with the Protocol Writer and the Principal Investigator

Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications, which includes identification of submission needs, preparation of required forms, tracking correspondence, and record retention.

Training & Mentorship (20%)

Participates in onboarding and training of new regulatory staff

Mentors and coaches clinical research staff on regulatory management of human subjects research, including interpretation of policies and forms, reporting obligations, and study documentation standards.

Identifies, develops, and implements job aids, work instructions, and workflow improvements in collaboration with CTO leadership and institutional stakeholders.

Provides regulatory consultation for complex studies, serving as an escalation point for troubleshooting and problem-solving.

Leads or co-leads regulatory educational events for CTO staff, including development of educational materials and periodic updates based on regulatory/policy changes.

The Masonic Cancer Center (MCC) is an NCI-designated Comprehensive Cancer Center dedicated to cancer research, education, and patient care for the citizens of Minnesota and the surrounding region. Since the time of the first award in 1997, there has been consistent growth of the membership and research base, enabling our center to further advance our knowledge and enhance care for our catchment area. We are driven to be the choice academic healthcare environment for patients, clinicians, scientists and students who seek exceptional, compassionate, precision cancer therapy; innovative clinical trials and prevention programs; cutting-edge research opportunities; and outstanding advanced education.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by Forbes as a Best Employer for Company Culture (2026), Best Employer for Women (2023, 2025, 2026), and Best Employer by State (2022-2026). In 2026, we also received Culture Excellence & Industry Awards recognition for employee appreciation and work-life flexibility.