Senior Research Regulatory Specialist - Pediatrics

The Medical College of Wisconsin, Inc.; Wauwatosa (WI); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Health coverage

Tuition reimbursement

Paid parental leave

Vacation and holidays

Job summary

The Medical College of Wisconsin seeks a Regulatory Program Leader to coordinate day-to-day clinical research regulatory activities. You will mentor Regulatory Specialists, prepare submissions, and ensure compliance with federal/state laws and institutional SOPs.

You will act as a liaison between sponsors, investigators, study teams, and review committees, guiding startup, ongoing oversight, and regulatory education across the Cancer Center CTO programs.

Qualifications

• Bachelor’s degree required.
• Minimum 4 years in compliance or healthcare field.
• CITI certification required within 30 days of hire.
• SoCRA and/or ACRP Certification preferred within 6 months.
• Experience in clinical research regulatory affairs preferred.

Responsibilities

• Draft and submit protocols, amendments, deviations, SAE reports and continuing progress reports with minimal supervision.
• Prepare IRB documents and provide guidance for drafting/modifying IRB submissions as needed.
• Manage regulatory activities in MCW/CTMS OnCore to meet requirements and track progress.
• Coordinate submissions for IND/IDE and maintain regulatory files with regular monitoring.
• Lead startup activities for studies and submissions to SRC, DSMB, IBC, Radiation Safety, MRI and ClinicalTrials.gov.
• Advise researchers and study team members on regulatory needs and annual education requirements.
• Collaborate with investigators on development of program materials and reports.
• Identify bottlenecks and propose process improvements; supervise/mentor Regulatory Specialists.

Skills

Regulatory compliance

Oral and written communication

Critical thinking

Attention to detail

Problem solving

Education

Bachelor's degree

Tools

OnCore CTMS

IRB system

Job description

SummaryCoordinate 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 ResponsibilitiesDraft 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 – AbilitiesKnowledge 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.QualificationsAppropriate 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 fieldRequired 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 RequirementsWork requires occasionally lifting moderate weight materials, standing, or walking continuously.Work EnvironmentOccasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.Sensory AcuityAbility to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.#LI-AV1Why MCW?Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options403B Retirement PackageCompetitive Vacation and Paid Holidays offeredTuition ReimbursementPaid Parental LeaveEmployee & Family Assistance Program (EFAP)Pet InsuranceOn campus Fitness Facility, offering onsite classesAdditional 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 OverviewFor a full list of positions see: MCW CareersAt 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.