Unblinded Clinical Research Coordinator II

Unblinded Clinical Research Coordinator II

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

Experience:

• 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

Knowledge and Skills:

• 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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