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    Clinical Research Associate

    Neurocentria, Inc.
    5+ years
    $100K/yr - $135K/yr
    Remote
    12 May 17, 2024
    Job Description
    Job Type: Full Time Education: B.S. Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Clinical Research Associate (CRA) / Senior CRA

    Employer: [Company Name]

    Location: United States

    Employment Type: Full-time

    Salary Range: $100,000/yr - $135,000/yr (Exact compensation may vary based on skills, experience, and location)

    General Position Overview

    The Clinical Research Associate (CRA) / Senior CRA is responsible for assisting with clinical trial management, site management, data review and cleaning, and occasionally leading the planning and development of the study set-up and execution. The role ensures compliance with protocols, ICH/GCP, regulatory requirements, and SOPs/Work Instructions.

    Key Accountabilities/Core Job Responsibilities

    Study Planning and Conduct:

    • Act as primary contact for vendors, investigational sites, and cross-functional teams, escalating to the study lead as necessary.
    • Support and occasionally lead the development/review of clinical study plans, presentations, and project/study-related documents including contracts/site payments.
    • Assist in the development and design of CRFs, participating in the EDC and IXRS specification process and UAT.
    • Oversee and mentor junior team members.
    • Perform in-house review of clinical data listings for completeness and accuracy, escalating issues as needed.
    • Manage clinical monitoring activities and overall site management, ensuring compliance with GCP and applicable regulations, and tracking site performance metrics.
    • Distribute study newsletters and track/report recruitment updates.
    • Assist in the development, approval, and distribution of study-related documents including CRFs, study protocols, study manuals, and other study tools.
    • Participate in clinical study team meetings.
    • Collaborate with internal cross-functional teams (e.g., Clinical Science, Biometrics, Regulatory Affairs) to ensure effective delivery of assigned project milestones.

    Site Monitoring Activities:

    • Ensure compliance with CFR, GCP, and internal SOPs and guidelines.
    • Communicate project progress, challenges, and opportunities regularly to Clinical Leadership.
    • Monitor clinical and laboratory data for accuracy and regulatory compliance, ensuring resolution of data queries.
    • Monitor safety issues and site evaluations, resolving with Clinical Team Leader.
    • Monitor SAE reporting and request follow-up information according to SOP.
    • Review protocol violations with the investigator and take corrective actions.
    • Reconcile drug accountability records and regulatory documents at sites.
    • Provide timely monitoring reports in accordance with SOPs.
    • Assist Data Management in resolving data queries.
    • Ensure availability of study supplies at sites and participate in other tasks as needed.
    • Perform pre-study site qualification visits to evaluate site adequacy.
    • Conduct ongoing monitoring visits to verify subject rights, data accuracy, and compliance.
    • Perform close-out visits and other trial completion activities.
    • Ensure site compliance with study protocols, safety, and investigational product accountability.
    • Assist in query writing and resolution.
    • Provide on-site training for investigators and site personnel.
    • Collaborate with cross-functional teams on safety data evaluation, compliance, and data management.
    • Communicate with clinical study team and sites to ensure adherence to timelines.
    • Organize study files, inventory, and materials.
    • Ensure clinical sites have adequate supplies to conduct the study.
    • Attend and/or perform site initiation visits.
    • Assist with mass communications, newsletters, and study coordinator training as needed.

    General:

    • Complete required corporate training on standards, policies, and work instructions.
    • Perform other work-related duties as assigned.

    Qualifications:

    • B.S. degree required.
    • 5+ years of CRA experience monitoring clinical trials in biotech, pharmaceutical, or CRO environment (8+ years for Sr. CRA).
    • Experience with trial conduct from start-up through close-out.
    • Working knowledge of ICH GCP and FDA regulations.
    • Ability to work effectively with minimal supervision.
    • Ability to multi-task and manage deliverables across all assigned trials.
    • Strong written and verbal communication skills.
    • Ability to travel frequently.
    • Self-motivated and able to work in a small team environment.

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