Remote Clinical Trial Regulatory Project Manager

Penn State University; United States; A distancia; USD 81.000 - 122.000; Jornada completa

Descripción de la vacante

The Beat Childhood Cancer (BCC) Research Consortium at Penn State College of Medicine in Hershey, PA, is seeking a full-time Clinical Trial Regulatory Project Manager. This remote role supports regulatory compliance, study start-up activities, and regulatory document management across 54+ sites in the US, Canada, and Spain, with travel as needed.

Ideal candidates will have strong IRB/cIRB, GCP, and FDA IND experience, plus ability to lead audits and cross-functional teams in a fast-paced

Formación

• Master’s degree required; 6+ years relevant experience.
• Experience with cIRB/IRB, GCP, FDA INDs.
• Ability to lead regulatory compliance programs.
• Strong written and verbal communication; team collaboration.

Responsabilidades

• Develop and oversee regulatory compliance program for the Beat Childhood Cancer Research Consortium (BCC).
• Manage sponsor-level regulatory responsibilities and Florence TMF/ISF management.
• Create and implement compliant action plans across 54+ sites.
• Ensure adherence to FDA, GCP, ICH and related regs.
• Lead internal and external audits; respond to non-compliance.
• Train and mentor staff; liaise with senior management and sites.

Conocimientos

Regulatory compliance

Study start-up

FDA IND knowledge

IRB/cIRB experience

Audit management

Documentation control

Communication skills

Team collaboration

Remote work

Educación

Master’s Degree

Herramientas

Florence eBinder

TMF/ISF management

Descripción del empleo

The Beat Childhood Cancer (BCC) Research Consortium at Penn State College of Medicine in Hershey, PA, is seeking a full-time Clinical Trial Regulatory Project Manager. This remote role supports regulatory compliance, study start-up activities, and regulatory document management across 54+ sites in the US, Canada, and Spain, with travel as needed.

Ideal candidates will have strong IRB/cIRB, GCP, and FDA IND experience, plus ability to lead audits and cross-functional teams in a fast-paced