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    Clinical Research Associate Iii (Medical Affairs)

    Cerus
    2+ years
    Not Disclosed
    Remote, USA
    10 Aug. 20, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

    About Cerus:

    At Cerus, our mission is to be the global leader and trusted partner in ensuring the safety and accessibility of blood for patients worldwide. Our innovative technology and dedicated services are critical to supporting blood centers and hospitals around the globe.

    Position Summary:

    We are seeking a Clinical Research Specialist to assist in the design and execution of clinical research projects. This role involves managing trial operations, ensuring data accuracy, and maintaining compliance with clinical objectives.

    Primary Responsibilities:

    • Clinical Trial Operations: Support the management of clinical trials by evaluating, monitoring, and facilitating data flow to ensure accuracy.
    • Site Management: Oversee investigational sites to ensure adherence to protocols and clinical objectives. Conduct site visits for pre-study, initiation, interim, and closeout phases.
    • Regulatory Compliance: Stay updated with Good Clinical Practices (GCPs) both domestically and internationally.
    • Documentation: Collaborate on writing study protocols, informed consent forms, manuals, and final reports. Develop case report forms, study start-up documents, and tracking tools.
    • Vendor and Budget Management: Work with CROs and vendors to meet clinical objectives. Assist with negotiating site budgets and managing payments.
    • Enrollment and Safety Tracking: Monitor subject enrollment and collect safety information for interim analyses. Participate in writing and reviewing SOPs for clinical operations.
    • Audit Readiness: Maintain central study files in an audit-ready state. Document and distribute meeting minutes for internal and external project teams.
    • Representation and Guidance: Act as the company's representative and provide guidance to other personnel as needed. Perform other related duties as required.

    Qualifications:

    • Education and Experience: Bachelor’s degree or equivalent with at least 5 years of clinical research experience.
    • Regulatory Knowledge: Strong understanding of FDA regulatory requirements and experience with FDA submissions and inspections.
    • Skills: Ability to work independently and in a fast-paced, ambiguous environment. Excellent communication, time management, and organizational skills. Broad knowledge of medical terminology and industry standards.
    • Travel: Willingness to travel domestically and internationally up to 25% of the time.
    • Attention to Detail: High level of accuracy and attention to detail.

    Benefits:

    Cerus offers a comprehensive benefits package designed to enhance employees' lives both professionally and personally, including:

    • Health Benefits: Medical, dental, vision, and domestic partner benefits.
    • Family Support: Paid maternity and paternity leave, healthcare and dependent care flexible spending accounts.
    • Insurance: Life and accidental death insurance, long-term and short-term disability insurance.
    • Financial: Matching 401(k), Employee Stock Purchase Plan (ESPP), and Restricted Stock Units (RSUs).
    • Additional Perks: Employee Assistance Program (EAP), legal and financial services, health club membership discounts, and tuition reimbursement.

    Compensation:

    For candidates based in the SF Bay Area, the base salary range is $113,000-$138,000 annually. Compensation may vary based on qualifications, skills, experience, and location. Base pay is part of a total compensation package recognizing and rewarding employee contributions.

    Equal Opportunity Employment:

    Cerus is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or disability.

    Apply Today:

    Join us in our mission to ensure the safety and accessibility of blood for patients worldwide. Apply now to be part of our dedicated team at Cerus.

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