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    Clinical Research Associate

    Boehringer Ingelheim Animal Health Usa
    3+ years
    Not Disclosed
    Fulton
    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)

    Employer: Boehringer Ingelheim

    Location: Hybrid (Onsite work required 2-3 days a week; relocation packages available for qualified hires)

    Employment Type: Full-time

    Job Description

    As a Clinical Research Associate (CRA) at Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to patients and customers. This role involves conducting in-house and external monitoring to ensure data accuracy and compliance with protocols, GCP/VICH requirements, FDA/CVM regulations, and BI SOPs. The CRA is responsible for ensuring the quality of study protocols, raw data, and reports supporting veterinary product registrations and claims. Duties include interacting with CROs/investigators, monitoring study status, managing study data, and performing procedures in compliance with regulatory guidelines.

    Key Responsibilities

    Study Documentation and Quality Control:

    • Ensure accuracy in documents related to in-house, CRO, and field studies, including study notebooks, reports, protocols, checklists, and analytical data.
    • Verify accuracy of drug dosages, accountability, numerical calculations, clinical signs, adverse events, and analytical results compared to clinic records.

    Site Visits and Monitoring:

    • Identify qualified CROs/FT investigators and conduct site visits to evaluate qualifications of the site, investigator, and research staff.
    • Conduct pre-study and ongoing monitoring visits in compliance with guidelines.
    • Monitor progress of in-house, field, and contract laboratory clinical studies, providing status reports.
    • Verify individual subject and overall drug accountability.
    • Identify and mitigate enrollment problems.

    Study Support and Documentation:

    • Collaborate with Clinical Scientists and Study/Trial teams in protocol development, CRF design, writing amendments, and creating site-training materials.
    • Assist Scientists in planning and implementing investigator meetings and/or webinars.
    • Monitor Adverse Event (AE) reporting and provide information to pharmacovigilance and regulatory affairs.
    • Ensure availability of all final study documentation for audits/inspections.

    Protocol and Regulatory Compliance:

    • Prepare protocols, data, reports, and other documents for submission to regulatory agencies.
    • Ensure protocol adherence and proper maintenance of study documentation.
    • Identify and report deviations to appropriate study personnel.
    • Conduct quality control audits of data entry and statistical reports.

    Requirements

    • Bachelor’s degree in relevant disciplines (e.g., biology, animal science, nutrition) with 1+ years of experience focusing on clinical studies, or 2+ years of experience in Human Pharma or Animal Health Research.
    • Good verbal and written communication skills.
    • Strong interpersonal skills and a collaborative team player.
    • Customer service orientation with the ability to deliver results in a fast-paced environment.
    • Solid organizational skills with a high degree of attention to detail.
    • Willingness to travel up to 60% of the time.
    • Fluent in English (reading, writing, speaking).

    Eligibility Requirements

    • Must be legally authorized to work in the United States without restriction.
    • Must be willing to take a drug test and post-offer physical (if required).
    • Must be 18 years of age or older.

    About Boehringer Ingelheim

    Founded in 1885 and family-owned ever since, Boehringer Ingelheim is a global company powered by 52,000 employees. We develop breakthrough therapies for both humans and animals and are committed to fostering a diverse and inclusive culture. We offer challenging work, learning and development opportunities, and a respectful and innovative working environment.

    Why Boehringer Ingelheim?

    • Opportunity to grow, collaborate, innovate, and improve lives.
    • Challenging work in a respectful and friendly global environment.
    • Commitment to employee learning and development.
    • Competitive compensation and benefits.

    Equal Opportunity Employer: Boehringer Ingelheim embraces diversity and inclusion. All qualified applicants will receive consideration for employment 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.

    To Learn More: Visit Boehringer Ingelheim.

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