Clinical Research Coordinator Lead

3 hours ago


Houston, Texas, United States Axsendo Clinical Full time
Job Overview

Axsendo Clinical Research is seeking a highly motivated and experienced Lead Clinical Research Coordinator to join our dynamic team. As a key member of our clinical research team, you will be responsible for coordinating and managing clinical research studies, ensuring compliance with regulatory requirements and company policies.

Key Responsibilities
  • Protocol Understanding:
    • Develop and maintain a thorough understanding of assigned research protocols.
    • Conduct prescreening of potential patients to ensure eligibility.
  • Site Staff Training:
    • Train site staff on the study's purpose and objectives.
    • Record attendance during training sessions to ensure compliance.
  • Enrollment Management:
    • Utilize the Electronic Medical Record (EMR) to screen eligible patients.
    • Facilitate patient qualification discussions with the Principal Investigator.
    • Report Adverse and Serious Adverse Events to IRB and Sponsor following guidelines.
    • Obtain and document informed consent following ICH/GCP and site SOPs.
    • Ensure timely and accurate data entry based on the ALCOA principle.
  • Monitoring Visit Preparation:
    • Organize and collect all source data in the electronic source system.
    • Resolve outstanding items from previous monitoring visits.
    • Address and close any queries from prior visits.
    • Keep temperature and accountability logs readily available.
  • Ongoing Study Oversight:
    • Plan subject visits as per protocol-specific schedules.
    • Prevent protocol deviations related to out-of-window procedures.
    • Coordinate with location administration to ensure space and resource availability.
    • Dispense/collect study medication with accurate Investigational Product accountability.
    • Collect and process subject laboratory specimens following protocol.
    • Complete case report forms (CRFs) and other patient tracking information accurately and promptly.
    • Maintain a comprehensive understanding of all data collection instruments and ensure accurate data collection according to the protocol.
    Requirements
    • Bachelor's degree in nursing, Allied Health, or Life Sciences.
    • 2+ years of clinical research coordinator experience is required.
    • Previous electronic CTMS experience preferred.
    What We Offer
    • Great company culture and tons of room for growth.


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