GCP Auditor

Job Title
: (Good Clinical Practice) GCP Auditor

Location
:
Paramus, NJ;
Hybrid, onsite 3 days/week (Tue, Wed, & Thu)

Schedule
: 40 hrs/week (8 hrs out of 7:30am to 5pm)

• 2+ years of relevant radiopharmaceutical experience
• BS degree in scientific, health care or related discipline
• Intensive GCP (Good Clinical Practice) and safety background
• Experience with both internal and external process and systems audits
• Strong knowledge of development policies, procedures and standards (SOPs, QMS)
• Ability to work with global clinical teams in developing objectives for audits of clinical studies
• 10% travel

• Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials
• Plan and conduct audits of specific clinical processes based on risk
• Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor
• Develop audit reports and distribute them to appropriate stakeholders
• Own and manage related clinical vendor non-conformances
• Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.)
• Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors
• Support the preparation, coordination, and participation of regulatory agency inspections
• Participate in and support quality improvement projects