Dispense and manage investigational products per sponsor protocols, maintain IP accountability and storage, perform data audits, train and support team members, ensure regulatory compliance and site documentation, and collaborate with investigators and sponsors on protocol execution.
DM Clinical Research is looking to hire an Unblinded Clinical Research Coordinator II to join our team. This individual 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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