Unblinded Clinical Research Coordinator II

Paycom - ATS; Irving (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

DM Clinical Research in Irving, Texas is seeking an Unblinded Clinical Research Coordinator II to support clinical trials. You will dispense Investigational Products (IP), manage IP accountability, and ensure regulatory documents are current while upholding blinding plans and study protocols.

The role requires 2+ years in clinical research, 1+ year as a coordinator (blinded or unblinded), and relevant certifications or degrees. Strong organization, communication, and data accuracy are essential.

Qualifications

• 2+ years of Clinical Research experience, inclusive of in-clinic experience.
• 1+ year of Clinical Research Coordinator experience, Blinded or Unblinded.
• LPN or CMA or Pharmacy Technician certification preferred.
• Associates degree required; Bachelor’s degree preferred.

Responsibilities

• Dispense Investigational Products (IP) as per protocol and Sponsor approval.
• Manage IP accountability and storage with temperature reporting.
• Assist in company start-up activities and onboarding of new staff.
• Audit clinical data for completeness and accuracy and ensure regulatory documents are up to date.
• Interpret schedules to plan IP compounding, preparation, and dispensing.
• Provide training and guidance to team members on study procedures and data entry portals.
• Coordinate with PI, Sponsor, study manager, and other coordinators to ensure compliance.

Skills

IP Dispensing

Clinical Research

Documentation

Communication

Education

Associates degree

Bachelor's degree preferred

LPN or CMA preferred

Pharmacy Tech Certification preferred

Tools

CRIO

Microsoft Excel

Google Suite

Microsoft Word

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.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