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    Clinical Project Assistant

    Genesiscare
    2+ years
    Not Disclosed
    Sydney
    12 June 10, 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, 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: Clinical Project Assistant

    Location: Sydney or Melbourne, Australia

    Company: GenesisCare

    GenesisCare is seeking a motivated Clinical Project Assistant to support the efficient management of clinical research projects. This role offers an excellent opportunity for individuals looking to enter or further develop their career in the clinical research field within a dynamic CRO environment.

    Responsibilities:

    • Support Clinical Project Managers and CRAs with administrative tasks.
    • Coordinate and implement clinical trial activities according to project timelines and regulatory requirements.
    • Manage meeting agenda and minutes preparation for project team meetings.
    • Generate project status reports and maintain project-specific training matrix.
    • Assist in tracking and evaluating project metrics for efficiency.
    • Prepare and collect essential study documentation during start-up phase and maintain documentation during study.
    • Drive the development, printing, shipping, and tracking of Investigator Site Files.
    • Manage project finance activities and site payments.
    • Maintain Trial Master Files (TMF) inspection readiness and accuracy.
    • Assist with the maintenance of project documentation in CTMS and eTMF.
    • Coordinate client and investigator meetings and related materials.
    • Coordinate activities with external vendors to ensure timely delivery of services and materials.
    • Assist with other project-related tasks as required.

    Qualifications:

    • Undergraduate degree in Life Sciences.
    • Minimum two years' experience in a clinical research setting, preferably in a CRO.
    • Experience with CTMS and eTMFs is desirable.
    • Understanding of ICH-GCP requirements is preferred.
    • Strong organizational skills with attention to detail.
    • Excellent written and verbal communication skills.
    • Proficiency in Microsoft Office suite.
    • Ability to work effectively in a fast-paced, team-oriented environment.
    • Desirable: Ability to work in an international environment with internal and external team partners.

    Benefits:

    • Opportunity to work with a vibrant team focused on providing the best patient experience and outcomes.
    • Internal and external training and development opportunities.
    • Close-knit internal community.
    • Access to free confidential support services for employees and their families.
    • Free access to thousands of LinkedIn training courses.
    • Range of benefits available, including Qantas and gym membership discounts, paid parental leave, and Bupa discount.

    About GenesisCare:

    GenesisCare is a team of over 1,300 highly trained healthcare professionals and support staff in Australia, dedicated to designing innovative treatments and care for people with cancer. The company aims to build a culture of care that is patient-focused and performance-driven.

    COVID-19 Vaccination Requirement:

    In line with the Public Health Order, all GenesisCare employees are required to be fully vaccinated for COVID-19.

    If you're passionate about innovation and making a difference in patient care, consider joining GenesisCare's team as a Clinical Project Assistant.

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