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    Senior Clinical Research Associate Contractor

    Biorasi
    2+ years
    Not Disclosed
    Remote, USA
    10 Dec. 11, 2024
    Job Description
    Job Type: Full Time 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 (CRA)
    Location: Remote / On-Site
    Employment Type: Full-time
    Posted: 12/11/2024

    About Biorasi:

    At Biorasi, we are growing and dedicated to supporting your career journey in an innovative, collaborative, dynamic, and evolving environment. We capitalize on your strengths while promoting a healthy work-life balance. As an award-winning, customer-focused, full-service clinical research organization, we help drive new therapies to patients. Join our growing global team and become a part of the expanding clinical research industry.

    Your Role:

    As a Clinical Research Associate (CRA), you will play a pivotal role in managing and monitoring clinical trial activities across sites. Your responsibilities include:

    • Site Visits: Plan, schedule, and conduct Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits, and Site Close-out Visits.
    • Report Writing: Write detailed reports and Investigator Follow-up Letters for all site visits.
    • Study Progress: Track study progress including regulatory/IRB submissions, recruitment, CRF completion, data queries, and resolution.
    • Project Updates: Provide project updates to the project management team on recruitment, enrollment, and site activities.
    • Material Delivery & Inventory: Organize delivery and return of investigational products, lab supplies, and study materials. Perform investigational product inventory checks.
    • Training & Communication: Assist with Investigator Meetings, conduct training for study sites, and establish effective communication with sites.
    • Document Management: Review and collect essential study documents for the eTMF and ensure compliance with protocol and GCP guidelines.
    • Compliance: Adhere to international GCP regulations and SOPs. Participate in quality assurance activities and resolve audit findings.
    • Resource Allocation & Support: Support the Clinical Trial Manager by reviewing site performance, providing feedback to CRAs, and assisting with the resolution of site issues.
    • Mentoring: Provide mentorship to associates on job performance, training, and professional growth.

    Your Profile:

    • Education: Bachelor’s Degree in biomedical sciences or related scientific discipline.
    • Experience: Minimum of 3 years of monitoring experience, preferably with a combination of clinical research coordination or other relevant clinical research experience.
    • Skills:
      • Sound knowledge of medical terminology and clinical monitoring processes.
      • Ability to travel up to 70%, depending on project needs.
      • Proficient in ICH GCP and worldwide regulatory requirements.
      • Strong leadership, planning, project management, verbal, and written communication skills.
      • Proficient in MS Office suite (Word, PowerPoint, and Excel).
    • Languages: Fluent in English (oral and written) and applicable local business language.

    Why Biorasi?

    • Employee Benefits: Thoughtfully designed benefits to enhance your health and well-being.
    • Diversity and Inclusion: Biorasi is committed to fostering a diverse and inclusive environment and is an equal opportunity employer.

    Apply Now:

    If you're ready to join an energetic, creative, and collaborative team, apply directly on our website at Biorasi Careers or email us at careers@biorasi.com.

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