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    Senior Clinical Research Associate

    Catalyst Clinical Research Llc
    3+ years
    Not Disclosed
    Remote, USA
    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: Senior Clinical Research Associate (CRA) – Oncology

    Location: Remote / Home-Based (U.S. Based)

    Travel: Up to 80% (Territory-based)

    About the Job:

    Catalyst Clinical Research is seeking an experienced Senior Clinical Research Associate (CRA) to monitor and manage clinical trial sites for biological and pharmaceutical development programs. In this role, you will ensure compliance with ICH/GCP, PhRMA guidelines, and Catalyst Clinical Research’s SOPs and practices. You will work closely with a clinical research team to support all stages of the clinical trial process, from site selection to study initiation, routine monitoring, and FDA audits.

    Key Responsibilities:

    • Site Monitoring & Management:

      • Travel up to 80% to monitor clinical trial sites, conducting site evaluations, study initiations, routine monitoring visits, site close-outs, and FDA audit preparations.
      • Develop and expand the selection of research study sites within your assigned territory.
      • Collaborate with site study staff and internal clinical research teams to report study site status, resolve issues, and respond to audit findings.

    • Collaboration & Communication:

      • Partner with the assigned clinical project team, including the Study Manager and Project Manager, to ensure the timely execution of clinical trials.
      • Assist with the planning and presentation of Investigator Meetings and contribute to data collection and FDA submission preparations.
      • Maintain effective communication with internal stakeholders and external vendors, including Data Managers, Statisticians, and Medical Monitors.

    • Operational & Budget Management:

      • Manage work activities in a cost-effective manner to ensure adherence to project budgets and timelines.
      • Maintain a home office if working remotely.

    • Regulatory Compliance & Continuous Learning:

      • Participate in internal and external meetings to stay updated on relevant regulations and clinical trial guidelines.
      • Ensure that trials are conducted in compliance with regulatory standards and sponsor requirements.

    Qualifications:

    • Education:
      • Bachelor’s degree in a science or health-related field, or equivalent industry experience (7+ years).
    • Experience:
      • Minimum of 5 years of clinical research experience with direct site monitoring experience (sponsor company or CRO).
      • At least 3 years of recent oncology clinical trial experience.
    • Knowledge & Skills:
      • Strong understanding of clinical trial monitoring, regulatory compliance, research methodology, and relevant regulations (ICH/GCP).
      • Exceptional organizational and time management skills.
      • Excellent written and verbal communication skills.
      • Strong computer skills and proficiency with clinical research software.
    • Other Requirements:
      • Ability to travel regularly within the assigned territory.
      • U.S. work authorization (we are unable to sponsor or take over sponsorship of an employment visa).

    About Catalyst Clinical Research:

    Catalyst Clinical Research is an equal opportunity employer committed to creating a diverse and inclusive work environment. We are dedicated to providing high-quality clinical trial services to our clients and advancing healthcare solutions. If you are a driven and experienced clinical research professional looking to join a dynamic team, we encourage you to apply.

    Apply Now for immediate consideration!

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