Remote Regulatory Specialist, Clinical Trials

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

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.