Clinical Supplies Associate
Location: Basking Ridge, NJ (Hybrid; onsite 2 days per week)
Type: 12 Month Contract
Schedule: M-F Day
Pay: $30-34/hour Responsibilities:
- Monitor and assess temperature data for clinical trial shipments and on-site storage.
- Collaborate with Quality to evaluate product impact and determine appropriate disposition of materials.
- Track and report temperature excursion metrics.
- Document temperature excursions in accordance with SOPs and regulatory requirements.
- Update the Interactive Response Technology (IRT) system to support resupply shipments.
- Coordinate and support investigations related to excursions.
- Partner with clinical supply chain, quality assurance, and clinical sites to drive timely resolution.
- Assist with additional clinical supply activities, including product destruction, study close-out, and filing documents in the electronic Trial Master File (e-TMF).
- Background in pharmaceutical supply chain, cold chain management, or stability management required.
- Understanding of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Strong attention to detail and communication skills.
- Experience working with IRT systems and documentation tools is a plus.
- 1-3 years minimum experience in related industry.
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