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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Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Internet Publishing
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