Unblinded Clinical Research Coordinator II (4021)

Posted 19 Days Ago
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48076, Southfield, MI, USA
In-Office
Junior
Healthtech • Professional Services • Biotech • Pharmaceutical
The Role
Dispense, compound, and manage investigational products per sponsor protocols; maintain IP accountability and storage; audit clinical data; support site startup, training, regulatory documentation, and coordinate with investigators and sponsors to ensure protocol compliance.
Summary Generated by Built In

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. Pharmacy Technicians, LPN's and CMA's are encouraged to apply!


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

Skills Required

  • Associates degree or 2 years of formal educational coursework
  • Bachelor's degree
  • Secondary or Foreign Medical Graduate
  • 2+ years of clinical research experience, including in-clinic experience
  • 1+ year of Clinical Research Coordinator experience (blinded or unblinded)
  • 1+ year using CRIO
  • LPN or CMA credential
  • Pharmacy Technician Certification
  • Completion of DMCR-required training including GCP, OSHA, and IATA
  • Ability to compound and dispense investigational products and maintain IP accountability
  • Computer proficiency with Word, Excel, Outlook, and Google Suite
  • Excellent written and verbal communication and customer service skills
  • Strong time-management, organization, attention to detail, and multitasking ability
  • Bilingual Spanish
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The Company
700 Employees
Year Founded: 2006

What We Do

DM Clinical Research is a multi-therapeutic network of clinical trial investigator sites headquartered in Houston, Texas. Founded in 2006, the company connects patients with trusted physicians to conduct cutting-edge research focused on quality and compassion, aiming to deliver advanced, preventative medicine to underserved communities. They operate a national network of dedicated research centers and physician-embedded sites throughout the United States.

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