Unblinded Clinical Research Coordinator II

Job Description

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, preferredExperience:

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 IATAKnowledge 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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