Regulatory Specialist

Overview

This role is part of the Clinical Trials Office within a cancer center environment. The position supports an excellent employee experience with a flexible work environment that may include flexibility in schedule and/or work location. Work is remote with infrequent in-person team functions. All employees are expected to follow applicable public health and safety procedures.

Responsibilities

Regulatory Management of Clinical Studies (80%)

• Provide regulatory guidance and direction to research team members to ensure compliance with applicable policies, procedures, and regulations.
• Serve as the primary contact for collection, organization, completion, and retention of essential regulatory documentation.
• Collaborate with the Principal Investigator, study coordinators, and other research team members to interpret protocols and edit consent documents as needed for clinical research studies.
• Prepare FDA, IRB, and other required reviewer applications, respond to stipulations, and coordinate communications and documentation through review processes until approvals are obtained.
• Track regulatory review submissions and approvals to ensure deadlines are met.
• Maintain the investigator site binder (essential regulatory documents) to ensure ongoing compliance and audit-readiness.
• Review outside safety reports and local serious adverse events and assess for regulatory reporting.
• Identify and report unanticipated problems involving risk to subjects or others (UPIRTSO) within the required timeline.
• Prepare for and participate in sponsor/CRO interactions and monitoring visits, which may include prequalification, site initiation, interim monitoring, and closeout visits.
• Serve as regulatory subject matter expert through all phases of a clinical study.
• Provide input during protocol development activities with the Protocol Writer and the Principal Investigator.
• Coordinate and facilitate submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications, including identification of submission needs, preparation of required forms, tracking correspondence, and record retention.

Training & Mentorship (20%)

• Participate in onboarding and training of new regulatory staff.
• Mentor and coach clinical research staff on regulatory management of human subjects research, including interpretation of policies and forms, reporting obligations, and study documentation standards.
• Identify, develop, and implement job aids, work instructions, and workflow improvements in collaboration with CTO leadership and institutional stakeholders.
• Provide regulatory consultation for complex studies as an escalation point for troubleshooting and problem-solving.
• Lead or co-lead regulatory educational events for CTO staff, including development of educational materials and periodic updates based on regulatory/policy changes.

Requirements

All required qualifications must be documented on application materials.

Required Qualifications

• BA/BS and minimum of 4 year of clinical research or related experience, or advanced degree plus 2 year of experience
• 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 and 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 Qualifications

• 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)

Compensation & 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

The organization 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

Note: While salary ranges provide a framework, most of the time the initial pay may not reach the maximum of the range. The offered salary is based on individual credentials and experience.

Location

Remote position with infrequent in-person team functions.

Employment Requirements

Any offer of employment is contingent upon successful completion of a background check. Criminal convictions do not automatically disqualify finalists from employment.

Equal Opportunity

The organization provides equal access 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.

How to Apply

Applications must be submitted online, including a cover letter and resume. Additional documents may be attached after application via the applicant portal in the “My Cover Letters and Attachments” section.