Lead Regulatory Specialist — Clinical Trials & Compliance

Medical College of Wisconsin; Milwaukee (WI); Presencial; USD 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Outstanding healthcare coverage

401(k) retirement package

Paid vacation and holidays

Tuition reimbursement

Parental leave

Descripción de la vacante

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.

Formación

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

Responsabilidades

• 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.

Conocimientos

Regulatory compliance

IRB submissions

Records management

Oral communication

Written communication

Critical thinking

Problem solving

Data utilization

Educación

Bachelor's degree

Herramientas

OnCore CTMS

Descripción del empleo

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.