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Clinical Research Associate - Veterinary Medicine

2+ years
Not Disclosed
10 Nov. 6, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Associate – Veterinary Medicine (Remote/Field-Based)

Location: Remote (U.S. Based) | Travel up to 25%


About the Role:

As a Clinical Research Associate (CRA) in the Veterinary Medicine division at American Regent Inc., you will play a key role in supporting the expansion of new veterinary products. You will assist the Senior Clinical Research Associate in executing essential operational and administrative functions needed to conduct veterinary clinical trials. This is a dynamic, multifaceted role where you will interact with various internal and external stakeholders, ensuring that veterinary clinical studies are conducted in compliance with industry standards and regulations.

You will be responsible for managing key elements of the clinical trial process, from study initiation to close-out, and assist in maintaining high standards of quality, accuracy, and uniformity across all study sites.


Key Responsibilities:

  • Vendor and Internal Coordination:
    Serve as the primary point of contact for internal functions such as Procurement, Finance, and Legal to facilitate clinical activities. Also, assist in managing relationships with external vendors, consultants, and CROs (Clinical Research Organizations).

  • Document Control:
    Act as the main coordinator for document control, ensuring proper version control during critical document reviews, amendments, and final publication of materials.

  • Study Coordination and Monitoring:
    Assist in coordinating and monitoring all study activities, including start-up, investigator training, study conduct, site monitoring, and close-out. Ensure that projects are executed efficiently and data are collected accurately across study sites.

  • Project Management Support:
    Participate in regular team meetings, track progress on assigned tasks, and facilitate the transfer of important information to management. Ensure that all clinical veterinary projects remain on schedule and meet regulatory compliance standards.

  • Clinical Protocol Support:
    Assist in drafting clinical study protocols, amendments, deviations, and final reports as required.

  • Continuous Improvement:
    Aid in the continuous improvement of clinical veterinary operational functions, refine processes, and develop tools to enhance the efficiency of clinical trials.

  • Compliance with Industry Standards:
    Utilize best practices and industry standards to ensure all clinical studies are completed in a timely and compliant manner.

  • Miscellaneous Tasks:
    Perform any other tasks as assigned by management to support the clinical development process.


Education and Experience Requirements:

  • Education:
    • Bachelor’s degree in a STEM-related field (Science, Technology, Engineering, or Mathematics) is required.
  • Experience:
    • A minimum of 2 years’ experience as a clinical study coordinator or monitor, preferably within the veterinary pharmaceutical industry.
    • Experience working with Good Clinical Practice (GCP) and/or Good Laboratory Practice (GLP) standards.
    • Familiarity with electronic data capture platforms and eClinical software.
    • Experience with Clinical Trial Management Systems (CTMS) is a plus.
  • Skills:
    • Proficiency in Microsoft Office, especially MS Word, and experience with cloud-based applications.
    • Strong written, verbal communication, and interpersonal skills.
    • Scientific writing proficiency is required for authoring study protocols and reports.
    • Strategic thinking, problem-solving skills, and the ability to manage multiple tasks simultaneously.
    • A proactive, growth-oriented mindset is highly valued.

Physical and Work Environment:

  • Travel:
    The role requires travel up to 25%, including overnight stays as needed.

  • Remote Work:
    Ability to work remotely with reliable internet access is essential.

  • Physical Requirements:
    The employee may need to occasionally lift and/or move up to 15 pounds.


Why American Regent?

American Regent Inc. is committed to creating a diverse, inclusive work environment where all employees feel valued. As an Equal Opportunity Employer, we ensure that all qualified applicants receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. We encourage individuals from all backgrounds to apply.

We are dedicated to making our careers page accessible to everyone. If you need assistance with the application process or have any questions regarding accessibility, please email us at hrtalentacquisition@americanregent.com.


Apply Now to join American Regent in advancing the future of veterinary clinical research!