Job Description

Job Title: Unblinded Clinical Research Coordinator

Location: Denver, CO

Pay Range: Up to $27 per hour

Schedule: Monday - Friday, 8:00 AM - 5:00 PM

Duration: 90-day contract with potential for extension or conversion to a permanent position based on performance and trial needs.

Position Summary:

This full-time role supports the day-to-day operations of clinical trials, with a strong focus on Investigational Product (IP) management while maintaining study integrity between blinded and unblinded staff. The Unblinded CRC serves as the subject-matter expert for IP handling and works closely with the Site Manager, study team, sponsors, and participants to ensure compliance with protocols and SOPs.

Key Responsibilities:

• Managing all aspects of Investigational Product (receipt, storage, dispensing, administration, accountability, and return/destruction)
• Maintaining the study blind and communicating appropriately with blinded and unblinded team members
• Conducting patient-facing visits, including vitals, ECGs, lab collection, and protocol-required procedures
• Completing accurate source documentation and EDC entry within required timelines
• Monitoring study activities for regulatory and protocol compliance
• Recording and reporting adverse events and resolving sponsor queries
• Participating in site audits, monitor visits, investigator meetings, and site initiation visits
• Maintaining temperature logs, pharmacy binders, and master study logs

This position reports directly to the Site Manager/Director and plays a critical role in ensuring studies run smoothly and compliantly.

Required Qualifications:

• Recent, heavy hands-on injection or vaccine administration experience, including independent injection administration in accordance with medication protocols
• Patient-facing clinical experience (Medical Assistant, Clinical Research Assistant, Research Assistant, LPN, etc.)
• Ability to work directly with study participants in a clinical setting
• Strong attention to detail and accurate documentation skills
• Ability to complete source documentation during patient visits and enter data into EDC within required timelines
• Ability to follow study protocols, SOPs, and regulatory requirements
• Basic understanding of GCP and FDA regulations (training acceptable)
• Strong communication and organizational skills
• Ability to work Monday–Friday, 8:00 AM–5:00 PM
• Ability to start ASAP

Preferred Qualifications:

• Previous experience as a Clinical Research Coordinator (CRC)
• Unblinded CRC or Investigational Product (IP) management experience
• Experience with drug accountability, temperature logs, and pharmacy binders
• Experience with Investigational Product preparation and administration
• Experience participating in monitor visits, audits, SIVs, and investigator meetings
• Experience using EDC systems and resolving sponsor queries

Work Environment:

• On-site clinical research site supporting active clinical trials and patient-facing activities.

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