Lead Unblinded Clinical Research Coordinator

3 weeks ago


Philadelphia, United States DM Clinical Research Full time
Job DescriptionJob DescriptionLead Unblinded Clinical Research Coordinator

The Lead Unblinded Clinical Research Coordinator will be responsible for dispensing Investigational Products (IP) as part of clinical research trials.

DUTIES & RESPONSIBILITIES
  • Lead Unblinded team operations
  • Compound and dispense prescribed IP as needed by Sponsor approved protocol.
  • Supervise and maintain records of all medications
  • Ensure compliance with study-specific blinding plans.
  • Provide consultative support regarding the preparation and dosing of drugs.
  • Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction.
  • Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials.
  • Understand and apply all applicable site procedures.
  • Ensure receipt and proper storage of IP and bioretention samples.
  • Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy.
  • Review most recent pharmacy manuals, protocols and provide input on clinical and pharmacy supply needs.
  • Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information.
  • Temperature reporting.
  • Any other duties/ tasks assigned by the manager

KNOWLEDGE & EXPERIENCE

Education:
  • High School Diploma or equivalent required
  • Foreign Medical Graduate is a plus
  • Pharmacy Technician Certification a plus
Experience:
  • Vaccine administration is required
  • Previous work experience as a Pharmacist or Pharmacy Technician is preferred
  • Previous work experience in clinical trials as an unblinded clinical research coordinator is preferred
Credentials:
  • LVN, RN, Pharmacy Technician Certification Preferred
  • FMG Preferred
Knowledge and Skills:
  • Extreme attention to detail (strict adherence to procedures and protocols is essential)
  • Computer proficiency, especially Word, Excel, Outlook, and Google Docs.
  • Excellent communication and customer service skills.
  • Outgoing personality Well-organized with attention to detail.
  • Must be able to multitask.
  • Bilingual (Spanish) preferred but not required

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