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.

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.

• 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.

• 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

All required qualifications must be documented on application materials.

• 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…