Senior Regulatory Lead, Clinical Trials

mcw; Milwaukee (WI); Sur place; USD 95 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health coverage

403B retirement

Paid time off

Tuition reimbursement

Parental leave

Employee assistance program

Résumé du poste

MCW is seeking a Regulatory Trials Leader to coordinate day-to-day administrative activities for the clinical research trials program, mentor Regulatory Specialists, and serve as the liaison between sponsors, investigators, and review committees. The role ensures compliance with Federal/State regulations and institutional SOPs while guiding a team of Regulatory Specialists and Coordinators.

The successful candidate will oversee IRB submissions, IND/IDE administration, and CTMS OnCore

Qualifications

• Bachelor's degree required.
• Minimum 4 years in compliance or healthcare.
• CITI certification required within 30 days of hire.
• SoCRA and/or ACRP Certification preferred within 6 months.

Responsabilités

• Coordinate regulatory submissions and ensure IRB alignment for protocols and amendments.
• Mentor Regulatory Specialists and coordinate with sponsors, investigators, and study team.
• Maintain IRB/FDA regulatory files and monitor IND/IDE activities.
• Oversee trial startup processes and regulatory submissions across committees (SRC, DSMB, etc.).
• Ensure compliance with federal/state laws and institutional SOPs.

Connaissances

Regulatory compliance

IRB submissions

CTMS OnCore

Team leadership

Regulatory knowledge

Formation

Bachelor's degree

Description du poste

MCW is seeking a Regulatory Trials Leader to coordinate day-to-day administrative activities for the clinical research trials program, mentor Regulatory Specialists, and serve as the liaison between sponsors, investigators, and review committees. The role ensures compliance with Federal/State regulations and institutional SOPs while guiding a team of Regulatory Specialists and Coordinators.

The successful candidate will oversee IRB submissions, IND/IDE administration, and CTMS OnCore