Unblinded Clinical Research Coordinator II

Dm Clinical Research Group; Irving (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

DM Clinical Research Group seeks an Unblinded Clinical Research Coordinator II to join our Irving, TX team. You will dispense Investigational Products (IP) and coordinate trial activities in alignment with study protocols.

Ideal candidates have 2+ years in clinical research (1+ year as a coordinator, blinded or unblinded) and IP handling credentials; bilingual Spanish is a plus. This role focuses on IP management, regulatory compliance, and team onboarding.

Qualifications

• 2+ years of Clinical Research experience, inclusive of in-clinic experience.
• 1+ year of Clinical Research Coordinator experience, Blinded or Unblinded, preferred.
• Experience dispensing Investigational Products (IP) and managing IP accountability.
• Familiarity with regulatory documents and site certifications.

Responsibilities

• Compound and dispense prescribed IP per protocol.
• Study IP management and IP accountability records.
• Provide training and guidance for new team members.
• Assist in start-up activities and maintain regulatory documentation.
• Audit clinical data for completeness and accuracy.
• Coordinate with PI, sponsor, and study staff to ensure protocol adherence.

Skills

Communication skills

Time management

Multitasking

Bilingual Spanish

CRIO familiarity

Education

Associate degree or 2 years of coursework

Bachelor's degree preferred

LPN / CMA or Pharmacy Technician Certification preferred

Foreign Medical Graduate (preferred)

Tools

Microsoft Word

Excel

Outlook

Google Suite

Job description

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 protocolStudy IP managementProvide training and guidance for new team membersAssist in all aspects of company start up activities as requiredSupervise and maintain records of all medicationsEnsure compliance with study-specific blinding plansPerform regular audits on the clinical data to assess percent completeness and accuracyAssist in onboarding training for new membersEnsure external sites’ regulatory documents and required site certifications are up to dateProvide consultative support regarding the preparation and dosing of drugsMaintain documentation of IP accountability: receipt, dispensing, return to sponsor/destructionInterpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trialsUnderstand and apply all applicable site proceduresEnsure receipt and proper storage of IP and bioretention samples, including temperature reportingDevelop operating procedures, guides and best practices for data entry portals and project workflowsInteract 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 managerKNOWLEDGE & EXPERIENCEEducation:Associates Degree required or 2 years of formal educational courseworkBachelor's degree, preferredSecondary or Foreign Medical Graduate, preferredExperience:2+ years of Clinical Research experience, inclusive of in-clinic experience, required1+ year of Clinical Research Coordinator experience, Blinded or Unblinded, required1+ year utilizing CRIO, preferredCredentials:LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant), preferredPharmacy Technician Certification, preferredCompletion 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 verbalExcellent time-management skillsAbility to remain composed under pressure and high-stress situationsOutgoing personalityWell-organized with attention to detail.Must be able to multitask.Bilingual (Spanish) preferred