Clinical Supply Associate

Responsibilities

• Supervise, plan and coordinate the clinical supplies activities within the clinical trials research projects.

• Ensure that goals and objectives of projects are accomplished within established time frames and budget guidelines.

• Ensure compliance with Good Manufacturing Practices and applicable state and federal regulatory authorities

• Participate in protocol review to identify clinical issues; establish time frames; develop budget projections; identify procedural and administrative issues; recommend amendments to study protocols as appropriate.

• Manage clinical supply activities including labeling, packaging, distribution of clinical trial supplies, randomization, development and maintenance of clinical trial database and drug accountability systems control.

• Direct the development of drug kit packaging and distribution systems.

• Provide oversight of domestic and international clinical supply shipments.

• Communicate with trial sponsor as needed.

• Prepare a variety of narrative and analytical reports, documents, and correspondence for contracting agencies, team members, participating departments and senior management regarding trial status.

• Recommend corrective action as necessary.