Research Regulatory Specialist - Pediatrics

Medical College of Wisconsin; Milwaukee (WI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health care coverage

403B retirement plan

Paid vacation/holidays

Tuition reimbursement

Parental leave

EFAP

Pet insurance

Job summary

Medical College of Wisconsin in Milwaukee seeks a Research Regulatory Specialist to gather regulatory documents and prepare IRB applications, amendments, and continuing reviews for human subject research. You will liaise with sponsors, investigators, and the IRB to support compliant study conduct.

The role emphasizes accurate document drafting, submission to the IRB system, and oversight of regulatory files for IND/IDE projects.

Qualifications

• Bachelor's degree required.
• 2 years in compliance or healthcare field.
• CITI certification within 30 days of hire.
• SoCRA and ACRP certification preferred.

Responsibilities

• Provide primary administrative support for the preparation of IRB documents and assist in drafting and submitting protocols, amendments, deviations, adverse events, continuing progress reports, and consent documents.
• Submit documents in the institution's electronic IRB system for initial approval, amendments, and continuing progress reports; review for accuracy and compliance.
• Support investigators with Investigator-Initiated IND/IDE applications and maintain IRB and FDA regulatory files for each IND/IDE.
• Facilitate study start-up activities with committees and manage ClinicalTrials.gov postings as required.
• Collaborate with Research Managers, Research Nurses, and Research Coordinators to complete all regulatory needs for assigned protocols.
• Identify and resolve problems related to protocol implementation and communicate issues to supervisors and investigators.
• Ensure regulatory activities comply with federal/state laws and SOPs.
• Assist with development of program materials including educational content, marketing materials, websites, forms and reports.
• Maintain program timelines by tracking deadlines and using CTMS to meet regulatory requirements; collect and disseminate data to stakeholders.
• Coordinate regulatory education notifications to study team members.
• Work with principal investigators to develop databases and files for the research program.
• Other duties as assigned.

Skills

Excellent communication

Critical thinking

Regulatory compliance knowledge

Education

Bachelor's degree

Job description

Summary

The Research Regulatory Specialist is responsible for gathering regulatory documents and preparing IRB applications, amendments, and continuing review submissions for human subject research, ensuring compliance with Federal, State, and Institutional Standard Operating Procedures. This role serves as the regulatory liaison with sponsors, principal investigators, study team members, and the IRB to support the successful conduct of research projects.

Primary Responsibilities

• Provide primary administrative support for the preparation of IRB documents. Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent documents. Modify documents as needed to meet IRB guidelines and research program requirements.

• Prepare and submit required documents in the institution's electronic IRB system for initial approval, amendments, and continuing progress reports. Review submissions for accuracy, completeness, and compliance using established checklists prior to submission.

• Support faculty with Investigator-Initiated IND/IDE applications. Maintain IRB and FDA regulatory files for each IND/IDE and ensure required routine monitoring is conducted.

• Facilitate study start-up activities, including submissions to committees such as the Scientific Review Committee, Data Safety Monitoring Board, Institutional Biosafety Committee, or Radiation Safety Committee. Manage ClinicalTrials.gov postings as required.

• Collaborate with Research Managers, Research Nurses, and Research Coordinators to identify and complete all regulatory needs for assigned protocols.

• Identify and resolve problems or obstacles related to research protocol implementation. Communicate issues to supervisors and study investigators.

• Ensure all regulatory activities comply with applicable federal and state laws, as well as institutional standard operating procedures.

• Assist investigators and research staff with the development of program materials, including educational materials, marketing content, websites, forms, and reports.

• Maintain program timelines by tracking deadlines for program components. Utilize the institution's Clinical Trial Management System (CTMS) to meet regulatory requirements and track activities. Collect, analyze, and disseminate program data, and report progress to stakeholders.

• Coordinate notifications to study team members regarding annual regulatory education requirements.

• Work with principal investigators to develop, implement, and maintain comprehensive databases and files related to the research program.

• Other duties as assigned.

Knowledge - Skills - Abilities

• Excellent oral and written communication skills are essential.

• Strong critical thinking, problem-solving, and attentiveness to detail required.

• Additional training in regulatory compliance strongly preferred.

Qualifications

Appropriate experience may be substituted for education on an equivalent basis.

Minimum Required Education: Bachelor's degree.

Minimum Required Experience: 2 years in compliance or healthcare field

Preferred Education: 2 years in compliance or healthcare field

Required Certification/Licensure(s): CITI certification required within 30 days of hire

Preferred Certification/Licensure(s): SoCRA and ACRP certification preferred.

Physical Requirements

Work requires occasionally lifting moderate weight materials, standing, or walking continuously.

Work Environment

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.

Sensory Acuity

Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.

Why MCW?

• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• Paid Parental Leave
• Employee & Family Assistance Program (EFAP)
• Pet Insurance
• On campus Fitness Facility, offering onsite classes
• Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

For a brief overview of our benefits see: Benefits Overview

For a full list of positions see: MCW Careers

At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring - Collaborative - Curiosity - Inclusive - Integrity - Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you. For more information, please visit our institutional website.

MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:

The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.