Senior Research Regulatory Specialist - Pediatrics

Medical College of Wisconsin; Milwaukee (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Outstanding healthcare coverage

401(k) retirement package

Paid vacation and holidays

Tuition reimbursement

Parental leave

Job summary

The Medical College of Wisconsin seeks a Regulatory Affairs leader to coordinate day-to-day administrative activities for the clinical research trials program. You will mentor Regulatory Specialists, gather regulatory documents, and prepare submissions to review committees ensuring compliance with laws and SOPs.

You will lead a team, liaise with sponsors and investigators, and help achieve Cancer Center CTO goals while managing regulatory education and program materials.

Qualifications

• Bachelor's degree required.
• 4 years in compliance or healthcare field.
• CITI certification required within 30 days; SoCRA/ACRP certification preferred within 6 months.

Responsibilities

• Coordinate IRB submissions and amendments with minimal supervision.
• Prepare documents in MCW/Froedtert electronic IRB system for approvals.
• Maintain IRB and FDA regulatory files for IND/IDE.
• Manage study startup activities and committee postings (SRC, DSMB, IBC, etc.).
• Advise CTO leadership and study team to identify and complete regulatory needs.
• Collaborate on program materials and reports.
• Maintain program timeline and use CTMS OnCore for regulatory tracking.
• Identify and communicate system/procedure improvements.
• Manage special projects as assigned; perform other duties.

Skills

Regulatory compliance

IRB submissions

Records management

Oral communication

Written communication

Critical thinking

Problem solving

Data utilization

Education

Bachelor's degree

Tools

OnCore CTMS

Job description

Summary

Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists, gathering regulatory documents, preparing review committee submissions, amendments and continuing review for human subject research ensuring compliance with Federal and State regulations, institutional policies, and Standard Operating Procedures. Perform as the regulatory liaison between sponsors, principal investigators, study team members, and review committees. Facilitate the achievement of the Cancer Center CTO goals. Lead a team of Research Regulatory Specialists and/pr Coordinators.

Primary Responsibilities

• Draft and submit protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent-to-treat documents with minimal supervision. Following IRB guidelines, occasionally prepare and/or provide guidance to Regulatory Specialists for drafting/modifying IRB documents as required by research program activities.
• Prepare and/or provide guidance to prepare the required documents in the MCW/Froedtert electronic IRB system for initial approval, amendments, and continuing progress reports. Review for accuracy and completeness, identify problems, and perform quality control based on established checklists prior to IRB submission.
• Coordinate support for Investigator-Initiated IND/IDE applications; maintain IRB and FDA regulatory files for each IND/IDE and ensure routine monitoring is conducted as required.
• Manage study start up activities, as necessary, including submissions to Scientific Review Committee (SRC), Data Safety Monitoring Board (DSMB), Institutional Biosafety Committee, Radiation Safety Committee, MRI Committee, and ClinicalTrials.gov postings.
• Advise CTO Research Managers, Research Nurses, Research Coordinators, and all other study team members to identify, prioritize, and complete all regulatory needs associated with each assigned protocol - including annual regulatory education requirements. Assure that the regulatory activities comply with various federal and state laws, and institutional standard operating procedures.
• Collaborate with investigators and CTO Research nurses/study coordinators on the development of program materials including educational materials, marketing materials, websites, forms, databases, and reports.
• Maintain program timeline including tracking deadlines for program components. Utilize MCW's Clinical Trial Management System (CTMS) OnCore to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.
• Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate proposed solutions or process improvements to supervisor and study investigators.
• Manage special projects as assigned by Manager and/or CTO Leadership with minimal supervision.
• Other duties as assigned.

Knowledge - Skills - Abilities

• Knowledge of biology, chemistry, mathematics, documentation, regulatory compliance, interpretation of regulations, and records management.
• Oral and written communication skills.
• Critical thinking, problem solving, and attention to detail.
• Data utilization and resource management.

Qualifications

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

Minimum Required Education: Bachelor's degree.

Minimum Required Experience: 4 years in compliance or healthcare field

Required Certification/Licensure(s): CITI certification required within 30 days of hire. SoCRA and/or ACRP Certified Clinical Research Professional preferred within 6 months of employment or promotion.

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.

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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.