Unblinded Clinical Research Coordinator II

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

Job summary

DM Clinical Research seeks a qualified Unblinded Clinical Research Coordinator II to join our team. You will dispense Investigational Products, manage IP inventory, and train new staff while ensuring compliance with blinding plans. The role involves audits, regulatory upkeep, and collaboration with investigators and sponsors.

Ideal candidates have 2+ years in clinical research, with at least 1 year as a CRC (blinded or unblinded). LPN/CMA and Pharmacy Technician certs are preferred.

Qualifications

• Associates Degree required or 2 years of formal educational coursework.
• 2+ years of Clinical Research experience, in-clinic experience included.
• 1+ year of Clinical Research Coordinator experience, Blinded or Unblinded.
• LPN or CMA preferred credentials.
• Pharmacy Technician Certification preferred.
• Completion of DMCR-required training (GCP, OSHA and IATA).

Responsibilities

• Dispense Investigational Products (IP) per sponsor protocol.
• Provide IP management and training for new team members.
• Assist in startup activities and regulatory document upkeep.
• Audit data for accuracy and completeness regularly.
• Maintain IP accountability records and storage conditions.
• Coordinate with PI, sponsor, and study coordinators on protocol requirements.
• Develop procedures for data entry portals and workflows.
• Interpret clinic schedule to plan compounding and dispensing.

Skills

Communication skills

Time management

Multitasking

Detail-oriented

Bilingual Spanish

Education

Associates Degree

Bachelor's degree preferred

Foreign Medical Graduate preferred

Tools

CRIO

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