Clinical Supply Specialist

Duties and responsibilities:

• Assist in planning and scheduling activities related to preparation and distribution of clinical supplies
o Coordinate company’s contract manufacturing packaging organizations to ensure clinical labeling, packaging and shipment/distribution needs for Cara’s clinical trials occur in a timely and cost-effective manner.
• Assist in evaluating needs for clinical studies
o Work with CMC Department to define trial supply strategy and determine if adequate supplies are available
o Proactively work with Clinical Team and CMC team to communicate needs for future trials
o Manage study inventory at depot(s) and clinical sites for each assigned clinical trial
o Support return of supplies at the end of each study(s)
o Support Clinical Team to ensure accountability is complete and accurate for assigned trial(s)
• Partnering with Clinical Team and Clinical Research Organizations to assist in IVRS/IWRS and implementation for assigned study(s)
• Participate at Clinical operation meetings as needed
• Work with Quality Assurance and Regulatory Affairs to resolve potential quality issues arising during clinical trials.

Qualifications include but not limited to:

• Minimum 3 years of experience in clinical supplies
• Bachelor’s degree in a scientific field
o Alternatively, a minimum of 7 years of experience in clinical supplies

Travel:

• Minimal travel required (not more than one domestic trip per year)

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