- Compound and dispense prescribed IP following Sponsor-approved protocols
- Manage study IP
- Provide guidance and training to new team members
- Participate in company start-up activities as needed
- Supervise and maintain medication records
- Ensure compliance with study-specific blinding plans
- Conduct regular audits on clinical data accuracy and completeness
- Participate in onboarding training for new staff
- Ensure external sites' regulatory documents are updated
- Offer consultative support on drug preparation and dosing
- Maintain documentation of IP accountability and handling
- Interpret clinic schedules and protocols for effective drug preparation and dispensing
- Apply site procedures efficiently
- Ensure proper receipt and storage of IP and samples
- Develop operational procedures and best practices for data entry and workflows
- Collaborate with key stakeholders to ensure protocol compliance
- Complete any other tasks delegated by the manager
- Associates Degree or equivalent educational coursework
- Preferably a Bachelor's degree
- Preferably a Secondary or Foreign Medical Graduate
- At least 2 years of Clinical Research experience, including in-clinic
- At least 1 year of Clinical Research Coordinator experience, Blinded or Unblinded
- Experience with CRIO is a plus
- Preferred Credentials:
- LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant)
- Pharmacy Technician Certification
- Completion of DMCR-required training, covering GCP, OSHA, and IATA
- Proficiency in various computer applications including Word, Excel, Outlook, and Google Suite
- Strong communication and customer service skills
- Effective time-management
- Ability to handle pressure and high-stress situations
- Outgoing personality
- Detail-oriented and well-organized
- Strong multitasking abilities
- Spanish bilingualism is a plus
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