Unblinded Clinical Research Coordinator II (4015)

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

Job summary

DM Clinical Research Group in CyFair – Houston, TX is hiring an Unblinded Clinical Research Coordinator II to join our team. You will dispense Investigational Products (IP) per sponsor-approved protocols and manage study IPs with oversight from the team.

The role requires 2+ years of Clinical Research experience and 1+ year as a CRC (blinded or unblinded). Strong communication, attention to detail, and ability to multitask are essential; bilingual Spanish is a plus.

Qualifications

• 2+ years of Clinical Research experience, in-clinic experience required.
• 1+ year of Clinical Research Coordinator experience, Blinded or Unblinded, required.
• LPN or CMA preferred; Pharmacy Technician Certification preferred.
• Completion of DMCR-required training, including GCP, OSHA and IATA.

Responsibilities

• Compound and dispense Investigational Products (IP) as per protocol.
• Study IP management and IP accountability records.
• Provide training and guidance for new team members.
• Assist in startup activities and ensure regulatory document compliance.
• Supervise and maintain records of medications; ensure blinding plans are followed.
• Audit clinical data for completeness and accuracy.
• Onboard and train new staff; support site onboarding.
• Ensure site regulatory documents and site certifications are up to date.
• Provide consultative support on drug preparation and dosing.
• Maintain IP receipt, dispensing, and destruction records.
• Interpret clinic schedule into IP compounding/dispensing timelines.
• Develop SOPs for data entry portals and project workflows.
• Coordinate with PI, sponsor, study manager, and coordinators on protocol requirements.
• Perform additional duties as assigned by the manager.

Skills

Computer skills

Excellent communication

Time management

Detail oriented

Organized

Multitask

Bilingual Spanish

Outgoings personality

Education

Associates Degree or 2 years coursework

Bachelor's degree preferred

Foreign/Secondary Medical Graduate preferred

Tools

CRIO

Microsoft Word

Microsoft Excel

Outlook

Google Suite

Job description

Job Details

Job Location: CyFair - Houston, TX 77065DM 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

Qualifications