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.
All your information will be kept confidential according to EEO guidelines.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.