Unmasked Clinical Research Coordinator - 258994

Seeking an Unmasked Clinical Research Coordinator in Lakewood, CO

The following information provides an overview of the skills, qualities, and qualifications needed for this role.

Location: Lakewood, CO (80228)

Schedule: Full time, onsite, 40 hrs a week

Employment: Contract to Hire

Study Focus: Phase II & III Clinical Trials

Study Type: Treatment/Injection Trials

Position Overview

The Unmasked Clinical Research Coordinator is responsible for supporting clinical research treatment visits and providing safe, high-quality patient care in accordance with International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, Institutional Review Board (IRB)-approved study protocols, study manuals, and organizational Standard Operating Procedures (SOPs).

This role works closely with Clinical Research Coordinators, Investigators, pharmacy teams, and other unmasked research staff to support the safe and efficient execution of Phase II and Phase III clinical trials. The Unmasked CRC will assist with treatment preparation and administration, patient monitoring, post-treatment assessments, investigational product (IP) management, documentation, and maintenance of treatment areas and equipment.

This position supports Phase II and III studies and does not involve gene therapy trials.

Key Responsibilities

• Support research patient treatment visits while maintaining compliance with study protocols, ICH-GCP guidelines, IRB requirements, and site SOPs.
• Conduct safe and appropriate aseptic and sterile-field techniques during treatment visits and procedures.
• Monitoring subject flow, patient care, and overall visit management.
• Observe, assist with, collect, and accurately document required study data during follow-up visits, including:
• Adverse events (AEs)
• Concomitant medications
• Treatment-related information
• Other protocol-required assessments
• Explain treatment processes and procedures to study participants in a clear and professional manner.
• Prepare and set up treatment rooms and ensure all necessary supplies and equipment are available prior to each day of patient visits.
• Prepare subjects for treatment and assist with treatment administration as required by the study protocol, pharmacy manual, and/or procedure manual.
• Promptly identify and report treatment-related adverse events, including medication errors, to the appropriate unmasked research staff and/or Investigator.
• Assist with the collection of aqueous humor samples for laboratory analysis, as required by study protocol.
• Perform intraocular pressure (IOP) checks following injections.
• Perform required post-treatment assessments, including:
• Finger count
• Hand motion
• Light perception
• Document post-injection evaluations and ensure appropriate documentation is completed by the treating Investigator.
• Monitor and document on-site temperatures for applicable equipment and maintain required daily temperature logs.
• Perform daily calibration of Tono-Pens and maintain appropriate calibration documentation.
• Ensure all instruments utilized by the unmasked team are properly accounted for, maintained, cleaned, and sterilized according to site procedures.
• Receive, store, track, and appropriately document receipt of Investigational Product (IP).
• Accurately document dispensed IP in the designated IP binder and/or applicable tracking system.
• Assist with maintaining accurate IP accountability and documentation throughout the study.
• Observe and assist with unmasked monitoring visits as needed.
• Complete and appropriately file injection worksheets and other study-specific treatment documentation.
• Maintain a clean, organized, and properly stocked treatment environment.
• Communicate effectively with investigators, coordinators, patients, monitors, pharmacy personnel, and other members of the research team.
• Maintain patient confidentiality and adhere to all applicable regulatory and organizational requirements.
• Perform other research-related duties and responsibilities as assigned based on organizational needs.

Required Skills & Qualifications

• Previous experience in a clinical research, ophthalmology, retina, medical assisting, or patient-care environment preferred.
• Ability to work effectively in a patient-facing clinical research environment.
• Strong understanding of or ability to learn ICH-GCP, study protocols, SOPs, and IRB requirements.
• Ability to safely perform or learn aseptic and sterile-field techniques.
• Strong attention to detail and ability to accurately document clinical and research information.
• Effective oral and written communication skills.
• Ability to work collaboratively with Clinical Research Coordinators, Investigators, and other members of the research team.
• Ability to prioritize multiple responsibilities while maintaining accuracy and patient safety.
• Demonstrated commitment to providing safe and appropriate patient care while following study protocols and regulatory requirements.

Preferred Qualifications

• Experience supporting Phase II or Phase III clinical trials.
• Ophthalmology or retina clinical experience.
• Experience with intravitreal injection support or ophthalmic treatment visits.
• Experience performing or assisting with IOP measurements.
• Familiarity with Tono-Pen calibration and use.
• Experience with aqueous humor or other biological specimen collection.
• Experience with investigational product receipt, storage, accountability, or dispensing.
• Previous experience working as an Unmasked Research Assistant, Medical Assistant, Ophthalmic Technician, or Clinical Research Assistant.
• Experience working with sterile/aseptic procedures and maintaining treatment rooms.

Compliance & Patient Safety

The Unmasked Research Assistant is expected to consistently deliver safe and appropriate patient care while adhering to study protocols, ICH-GCP guidelines, IRB requirements, SOPs, and applicable regulatory requirements. Patient safety, data integrity, accurate documentation, and protocol compliance are essential components of this position.

Work Environment

This is a patient-facing clinical research position within a clinical/ophthalmology research setting. xhyhwjd The role requires close collaboration with the research team and may involve frequent interaction with study participants, Investigators, Clinical Research Coordinators, monitors, pharmacy personnel, and other clinical staff.