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Unblinded Clinical Research Coordinator II
2 months ago
Unblinded Clinical Research Coordinator II will be responsible for dispensing Investigational Products (IP) as part of clinical research trials.
DUTIES & RESPONSIBILITIES
- Compound and dispense prescribed IP as needed by Sponsor approved protocol
- Study IP management
- Provide training and guidance for new team members
- Assist in all aspects of company start up activities as required
- Supervise and maintain records of all medications
- Ensure compliance with study-specific blinding plans
- Perform regular audits on the clinical data to assess percent completeness and accuracy
- Assist in onboarding training for new members
- Ensure external sites’ regulatory documents and required site certifications are up to date
- 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, including temperature reporting
- Develop operating procedures, guides and best practices for data entry portals and project workflows
- Interact with Principal Investigator, sponsor, study manager and other study coordinators to ensure all aspects of protocols and study requirements are understood.
- Any other duties or tasks assigned by the manager
KNOWLEDGE & EXPERIENCE
Education:
- Associates Degree required or 2 years of formal educational coursework
- Bachelor's degree, preferred
- Secondary or Foreign Medical Graduate, preferred
- 2+ years of Clinical Research experience, inclusive of in-clinic experience, required
- 1+ year of Clinical Research Coordinator experience, Blinded or Unblinded, required
- 1+ year utilizing CRIO, preferred
- Credentials:
- LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant), preferred
- Pharmacy Technician Certification, preferred
- Completion of DMCR-required training, including GCP, OSHA and IATA
- Computer proficiency, especially Word, Excel, Outlook, and Google Suite products.
- Excellent communication and customer service skills, both written and verbal
- Excellent time-management skills
- Ability to remain composed under pressure and high-stress situations
- Outgoing personality
- Well-organized with attention to detail.
- Must be able to multitask.
- Bilingual (Spanish) preferred
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