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    Clinical Research Associate (Cra, In-House)

    Longboard Pharmaceuticals
    5+ years
    $130K/yr - $150K/yr
    La Jolla
    12 May 17, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 or Senior CRA; In-House)

    Location: San Diego, CA (Hybrid, 2-3 days a week in office)

    Department: R&D: Clinical Operations

    Reporting To: Director, Clinical Line Management

    People Manager: No

    FLSA Status: Exempt

    Position Type: Full-time

    Position Summary

    The Clinical Research Associate (CRA) supports global and regional clinical trial managers and trial leaders in the planning, designing, executing, monitoring, and reporting of clinical trials. The role involves partnering with internal and external stakeholders to align activities with study projects and timelines, ensuring regulatory compliance and quality in document management, data management, and clinical operations.

    Key Responsibilities

    • Study Planning and Execution: Support clinical trial managers and leaders in planning, executing, and reporting clinical trials, ensuring alignment with study timelines, budgets, SOPs, GCP, and regulatory guidelines.
    • Document Management: Collect, review, and ensure completeness and accuracy of essential regulatory and administrative documents. Assist in the development and review of study documents and plans.
    • Site Management: Perform investigator site recruitment and feasibility assessments. Conduct co-monitoring or observational visits as needed. Monitor study progress, data management, and query resolution.
    • Compliance and Quality Control: Ensure compliance with FDA/GCP/ICH guidelines and regulatory requirements. Conduct quality control audits of data entry and statistical reports.
    • Collaborative Interaction: Work with Technical Operations, CTAs, and other functional areas to support clinical trial activities. Interact with clinical operations team members and investigator site staff to relay study issues and updates.
    • Process Improvement: Participate in the development and improvement of departmental processes, best practices, and tools related to clinical trial management.
    • Protocol Adherence: Evaluate execution of study protocols at the site level, identifying and escalating serious issues as needed. Ensure adherence to protocol and proper documentation.
    • Regulatory Compliance: Support oversight of clinical trials to ensure compliance with protocols, federal and local regulations, GCP, and company policies.
    • Travel: Willingness to travel up to 35%.

    Minimum Requirements

    • Bachelor’s degree, preferred.
    • 5+ years of relevant and progressive experience with clinical trials.
    • Experience in all stages of clinical trial conduct and a strong understanding of clinical trial processes and medical terminology.
    • Experience in managing and monitoring CRO and investigative sites, preferred.
    • Proficiency in CTMS, EDC, TMS, and related software.
    • Strong written and verbal communication skills.
    • Knowledge of ICH GCP, IRB/IEC, and local regulatory authority regulations.
    • Motivated to work in a fast-paced, high-accountability environment.
    • Experience with bio-samples and storage of 3rd party data, preferred.
    • Experience in Longboard’s focused therapeutic areas, preferred.

    About Longboard Pharmaceuticals

    At Longboard Pharmaceuticals, we aim to enhance the lives of individuals battling profound neurological conditions. We foster an inclusive company culture and pride ourselves on providing an inviting work environment. We seek dynamic, talented, and dedicated individuals to join our team.

    Compensation and Benefits

    • Base Salary: $130,000 - $150,000 per year (dependent on experience and education).
    • Benefits Package: Includes bonus opportunities, stock options, medical, dental, and vision plans, 401(k) with company match, flexible time off, and 11 paid holidays per year.
    • Perks: On-site gym, garage parking, company-sponsored events, flexible spending account for medical care, life insurance, and short/long-term disability plans.

    Learn more about Longboard Pharmaceuticals: Visit our website.

    Equal Opportunity Employer

    Longboard Pharmaceuticals, Inc. provides equal employment opportunities without regard to race, color, creed, religion, national origin, age, ancestry, citizenship status, marital status, gender identity or expression, sexual orientation, disability, veteran status, pregnancy, genetic information, or any other characteristic protected by law. 

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