Senior Research Regulatory Specialist - Pediatrics

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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