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    Sr Cra- 616237

    Planet Pharma
    4+ years
    $110K - $135K
    San Francisco
    10 Nov. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Opportunity: Senior Clinical Research Associate (Sr CRA)
    Location: Hybrid (3 days in office: 2 core days, 1 flex day)
    Industry: Pharmaceutical / Biotech
    Experience Required: Diabetes or Obesity experience preferred

    Position Summary:

    We are seeking a Senior Clinical Research Associate (Sr CRA) to independently manage the clinical aspects of small to medium-sized clinical studies, or with supervision, take on significant management responsibilities in large-scale studies. This position requires close collaboration with cross-functional teams, vendors, and clinical research organizations (CROs) to ensure compliance with protocols, good clinical practices (GCP), and the study’s overall objectives. This is a hybrid role requiring 3 days per week in the office.

    Essential Duties and Responsibilities:

    • Study Execution: Ensure quality execution of assigned clinical protocols following SOPs, ICH/GCP, and corporate goals.
    • Study Support: Assist the Study Lead in all aspects of clinical studies including start-up, enrollment, maintenance, and closeout phases.
    • Protocol Development: Participate in protocol development and amendments, coordinating with medical writing teams.
    • Vendor Oversight: Manage study vendors (e.g., IRT, eCOA, cardiac safety) to ensure high-quality data and adherence to study timelines.
    • Site Management: Oversee clinical sites, provide escalation support, and monitor CRO activities. Assist with IP shipment and reconciliation.
    • Study Documentation: Assist with the creation and review of study materials such as informed consent forms, monitoring tools, and workflows.
    • Trial Master File (TMF): Ensure TMF is maintained and support periodic audits.
    • Vendor & CRO Collaboration: Assist with RFP review, bid defenses, vendor selection, and contract negotiations.
    • Study Timelines & Budgets: Contribute to the development of study timelines, budgets, and ensure all study goals are met on time and within budget.
    • Regulatory & Compliance: Support regulatory submissions, monitor data quality, and ensure compliance with all trial documentation and study-specific processes.

    Travel:

    Up to 30% travel required.

    Requirements:

    Education:

    • Bachelor’s degree in a relevant scientific discipline.

    Experience:

    • Minimum 4 years of clinical trial management experience in a Sponsor company, CRA/field monitor, or CRO setting.
    • Global experience is a plus.
    • Experience in Diabetes or Obesity clinical trials is highly preferred.

    Skills:

    • Strong understanding of the drug development process, ICH/GCP guidelines, and clinical trial processes.
    • Excellent interpersonal, problem-solving, organizational, and communication skills.
    • Ability to manage and prioritize tasks under pressure.
    • Proficiency in Microsoft Office tools (Word, Excel, etc.).

    Ideal Candidate Traits:

    • Self-motivated with the ability to motivate others.
    • High attention to detail and ability to prioritize critical tasks.
    • Strong teamwork skills and the ability to collaborate across departments and with external vendors.

    Why Apply?

    • Hybrid work environment for flexibility and balance.
    • Join a collaborative team with opportunities for growth and impact in clinical research.
    • Competitive compensation and benefits package.

    If you have experience in clinical trials, particularly within Diabetes or Obesity studies, and meet the required qualifications, we encourage you to apply.

    For more information or to apply, please contact our recruitment team.

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