Senior Clinical Trials Regulatory Lead

The Medical College of Wisconsin, Inc.; Wisconsin; In loco; USD 85.000 - 115.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Tuition reimbursement

Dental and vision coverage

Flexible spending account (FSA)

Paid time off and holidays

Descrizione del lavoro

The Medical College of Wisconsin, Inc. in Wisconsin is seeking a Regulatory Program Manager to coordinate day-to-day administrative activities of the clinical research trials program.

You will mentor Research Regulatory Specialists, gather regulatory documents, and prepare submissions to review committees to ensure compliance with federal and state regulations, institutional policies, and SOPs. As the regulatory liaison between sponsors, investigators, study teams, and review committees, you

Competenze

• Bachelor’s degree required; 4 years in compliance or healthcare field.
• CITI certification required within 30 days of hire.
• SoCRA and/or ACRP certification preferred within 6 months of employment.
• Strong knowledge of biology, chemistry, and regulatory documentation.

Mansioni

• Draft and submit protocols, amendments, deviations, and progress reports with minimal supervision.
• Guide regulatory specialists for drafting IRB documents as required by activities.
• Prepare required documents in the MCW/Froedtert electronic IRB system for approvals and continuing reviews.
• Coordinate support for Investigator‑Initiated IND/IDE applications and maintain regulatory files.

Conoscenze

Regulatory compliance

IRB submission

Leadership

Project management

Communication skills

Formazione

Bachelor's degree

Strumenti

OnCore CTMS

Descrizione del lavoro

The Medical College of Wisconsin, Inc. in Wisconsin is seeking a Regulatory Program Manager to coordinate day-to-day administrative activities of the clinical research trials program.

You will mentor Research Regulatory Specialists, gather regulatory documents, and prepare submissions to review committees to ensure compliance with federal and state regulations, institutional policies, and SOPs. As the regulatory liaison between sponsors, investigators, study teams, and review committees, you