Job Description

Seeking a Clinical Research Coordinator (Masked – IP Prep) to join our clinical trials team. This role involves investigational product (IP) preparation under masking/blinding protocols, coordinating patient visits, maintaining regulatory compliance, and upholding GCP standards. Experience with study drug handling, patient coordination, and blinded trials preferred.

✅ Full Job Description:

Position: Clinical Research Coordinator (Masked – IP Prep)

Location: Lakewood, CO

Employment Type: Full time; Contract to Hire

Position Overview:

We are seeking a highly organized and detail-oriented Clinical Research Coordinator (CRC) with experience in masked/blinded clinical trials and investigational product (IP) preparation . In this role, you will be responsible for preparing study drugs per protocol while maintaining masking integrity. You will also coordinate patient visits, manage trial documentation, and ensure compliance with regulatory and ethical guidelines.

Key Responsibilities:

• Prepare and dispense the investigational product (IP) under masking/blinding procedures.
• Maintain strict compliance with study masking protocols to protect trial integrity.
• Coordinate and conduct patient visits, including scheduling, informed consent, and follow-up.
• Manage study documentation, regulatory submissions, and reporting requirements.
• Ensure drug accountability, temperature logs, and inventory documentation.
• Work collaboratively with investigators, study sponsors, and monitors while maintaining masking restrictions.
• Monitor patient safety and protocol adherence throughout the study.
• Follow all GCP , ICH , and institutional policies and procedures.

Qualifications:

• 2+ years of experience as a Clinical Research Coordinator, Research Nurse, or related role in clinical research.
• Direct experience in masked/blinded trials and IP preparation preferred.
• Familiarity with investigational product handling, drug accountability, and blinding techniques.
• Strong organizational and communication skills.
• Certification in Clinical Research (CCRP, CCRC) preferred but not required.
• Knowledge of FDA regulations and Good Clinical Practice (GCP) guidelines.

Preferred Experience:

• Patient-facing coordination experience.
• Study drug dispensing, pharmacy tech, or compounding experience a plus.
• Strong attention to detail and protocol compliance.

Why Join Us:

• Be a key part of innovative clinical trials impacting patient care.
• Collaborative, mission-driven research environment.
• Opportunities for training and professional growth.

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