Research Regulatory Specialist - Pediatrics

The Medical College of Wisconsin, Inc.; Wauwatosa (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

The Research Regulatory Specialist at The Medical College of Wisconsin is responsible for gathering regulatory documents and preparing IRB applications, amendments, and continuing reviews for human subject research, ensuring compliance with federal, state, and institutional procedures.

This role serves as the regulatory liaison with sponsors, PI and study teams, supporting successful conduct of research projects and adherence to regulatory requirements.

Qualifications

• Bachelor’s degree required.
• 2 years in compliance or healthcare field.
• CITI certification required within 30 days of hire.
• SoCRA and ACRP certification preferred.
• Experience may be substituted for education on an equivalent basis.

Responsibilities

• Provide primary administrative support for the preparation of IRB documents.
• Draft and submit protocols, amendments, deviations, adverse events, continuing progress reports, and consent documents.
• Modify documents to meet IRB guidelines and program requirements.
• Submit documents in the institution's electronic IRB system for initial approval, amendments and continuing reports.
• Review submissions for accuracy, completeness, and compliance using checklists.

Skills

Regulatory compliance

Excellent communication

Attention to detail

Critical thinking

Documentation skills

Education

Bachelor’s degree

Tools

CTMS

IRB submission systems

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.

Benefits

• 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.

Our 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.

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.

About Us

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.

Together, we can build a healthier world. A student, an educator, a scientist and a community leader — alone, they can do many things. Together, the question isn’t what they can do, but what can’t they. The Medical College of Wisconsin (MCW) brings together the most inquisitive, passionate minds in science, medicine, education and community engagement to tackle today’s toughest challenges in health and society. Academic medicine is at the center of where scientists, physicians and students work hand-in-hand with the community to ask the most important questions and fuel the cycle of innovation that shapes the future of medicine. Medical College of Wisconsin The tireless pursuit of knowledge and the power of academic medicine is at the core of everything we do at MCW. Bringing together the world’s top scientists and clinicians, inspired students and invested communities, we are driven to solve the most complex challenges in health and society. With around 1,600 full-time and part-time faculty and approximately 3,500 full-time employees, MCW is home to a diverse group of thought leaders working in collaboration to pioneer pathways to a healthier world and drive a continuous cycle of life-changing discovery.