Lead Unblinded Clinical Research Coordinator
3 weeks ago
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
- 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
- LVN, RN, Pharmacy Technician Certification Preferred
- FMG Preferred
- 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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