Unblinded Clinical Research Coordinator II (4076)

Dm Clinical Research Group; New York (NY); On-site; USD 64,000 - 77,000; Full time

Job summary

DM Clinical Research is seeking an Unblinded Clinical Research Coordinator II to join our Brooklyn, NY team. The role focuses on dispensing Investigational Products (IP) and ensuring protocol compliance in clinical trials.

Responsibilities include IP dispensing and management, training new staff, and maintaining regulatory and study documentation while coordinating with investigators and sponsors. Requires 2+ years of CRC experience and familiarity with CRIO; bilingual Spanish is a plus.

Qualifications

• Associate degree or 2 years of coursework required.
• Bachelor's degree preferred.
• Secondary or Foreign Medical Graduate preferred.
• 2+ years of Clinical Research experience required (in-clinic acceptable).
• 1+ year of CRC experience, Blinded or Unblinded, required.
• 1+ year utilizing CRIO preferred.
• LPN or CMA or Pharmacy Tech cert preferred.
• DMCR training including GCP/OSHA/IATA completed.

Responsibilities

• Dispense IP per sponsor protocol.
• Manage study IP inventory and records.
• Train and guide new team members.
• Support startup activities.
• Supervise medication records and storage.
• Ensure compliance with blinding plans.
• Audit clinical data for accuracy.
• Onboard and train new staff.
• Maintain regulatory documents and site certifications.
• Provide dosing consultation for IPs.
• Document IP receipt, dispensing, and destruction.
• Translate clinic schedules to actionable IP prep times.
• Apply all site procedures.
• Ensure IP and sample storage with temperature logs.
• Develop SOPs and data-entry workflows.
• Collaborate with PI, sponsor, and coordinators.

Skills

Communication skills

Time management

Multitasking

Attention to detail

Organization

Computer proficiency

Bilingual Spanish

Education

Associate degree

Bachelor's degree

Foreign medical graduate

Tools

CRIO

Job description

Job DetailsJob Location: Brooklyn, NY (AOM) - Brooklyn, NY 11220Salary Range: $64,000.00 - $77,000.00 SalaryDM Clinical Research is looking to hire anUnblinded Clinical Research Coordinator IIto 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 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