Regulatory Specialist

University of Minnesota; Minneapolis (MN); Remote; USD 66,000 - 77,000; Full time

Benefits offered by this job

Public Service Loan Forgiveness (PSLF)

Wellbeing program

Professional development opportunities

Flexible work environment

Job summary

The University of Minnesota's Masonic Cancer Center Clinical Trials Office is seeking a Regulatory Manager to oversee regulatory submissions and documentation for clinical studies. The role emphasizes compliance with FDA and GCP regulations, IRB interactions, and audit readiness, with a strong focus on collaboration with investigators and study teams.

Hybrid/remote work is available with required in-person dates.

Qualifications

• BA/BS and minimum of 2 years of clinical research or related experience or combination totaling 6 years.
• Experience with clinical research trials regulations (FDA and GCP).
• Experience submitting materials to IRB and following policies.
• Knowledge of basic anatomy and medical terminology.
• Excellent organizational skills and ability to prioritize multiple tasks.
• Strong written and verbal communication skills; proficient with Microsoft Office.

Responsibilities

• Provide regulatory guidance to ensure compliance with applicable policies and regulations.
• Serve as primary contact for collection, organization, and retention of regulatory documentation.
• Collaborate with investigators and study team to interpret protocols and edit consent documents as needed.
• Prepare FDA, IRB, and other required submissions and respond to stipulations.
• Track regulatory submissions and approvals to meet deadlines.
• Maintain investigator site binder for audit-readiness and ongoing compliance.
• Review safety reports and report unanticipated problems as required.
• Support sponsor/CRO interactions and monitoring visits.
• Serve as regulatory SME through all study phases.
• Provide input during protocol development and coordination of IND/IDE submissions.

Skills

Regulatory management

FDA/GCP knowledge

IRB submissions

MS Office proficiency

Organization & prioritization

Communication skills

Education

BA/BS in a relevant field

Certified Clinical Research Professional (preferred)

Tools

OnCore

Florence eBinders

Smartsheet

Box

Google Workspace

IRB systems

Job description

About the Job

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.

This is a hybrid position, but primarily remote, and mandatory dates in the office would be required. Due to position needs, the applicant must live or be willing to relocate to MN or live in a surrounding boarder state within 100 miles (or 2 hour drive) of the Twin Cities metro area.

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

Qualifications

All required qualifications must be documented on application materials.

REQUIRED QUALIFICATIONS

• BA/BS and minimum of 2 years of clinical research or related experience or combination of education and related experience totaling 6 years.


• Experience with clinical research trials regulations (e.g., Food and Drug Administration (FDA) and Good Clinical Practice (GCP)).


• Experience submitting materials to IRB and with following policies and procedures.


• Knowledge of basic anatomy and medical terminology


• Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment


• Strong written and verbal communication skills, including computer proficiency in a PC environment with Microsoft Office products.

Preferred

• Certified Clinical Research Professional (or similar) certification


• Experience in oncology clinical research setting


• Previous professional experience on a clinical research project team or similar environment


• Experience writing and adapting patient consent forms for research studies


• Experience using UMN health sciences software and document management systems (e.g., OnCore, Florence eBinders, Smartsheet, varying IRB systems, Box, Google Workspace/G Suite)

About the Department

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.

Pay and Benefits

Pay Range: $66,000 - $77,000; depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off


• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program


• Low-cost medical, dental, and pharmacy plans


• Healthcare and dependent care flexible spending accounts


• University HSA contributions


• Disability and employer-paid life insurance


• Employee wellbeing program


• Excellent retirement plans with employer contribution


• Public Service Loan Forgiveness (PSLF) opportunity


• Financial counseling services


• Employee Assistance Program with eight sessions of counseling at no cost


• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

While our salary ranges provide a framework, it is important to note that most of the time, the initial pay may not reach the maximum of the range. This approach ensures that compensation reflects the value and unique contributions of each candidate while maintaining equity within our organization. As part of our commitment to fair and equitable compensation, please be aware that the salary offered to incoming candidates will be based on their individual credentials and experience.

Diversity

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

Employment Requirements

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

About University of Minnesota

The University of Minnesota, Twin Cities (UMTC)

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.