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    Clinical Affairs Associate - Houston, United States - Healgen Scientific

    Healgen Scientific
    Healgen Scientific Houston, United States

    3 weeks ago

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    Description
    Job Description

    Job Description
    We are seeking a highly motivated and detail-oriented Clinical Affairs Associate to join our dynamic team.

    The successful candidate will play a crucial role in supporting clinical affairs activities, ensuring compliance with regulatory requirements, and contributing to the overall success of our clinical studies.

    You will have an opportunity to play a significant part in making the latest diagnostic tests and devices available quickly and safely to clinicians and their patients.


    Assist in the planning, coordination, and execution of clinical studies.

    Assist in drafting clinical study protocols and procedures, including informed consent forms, monitoring plans, and data collection forms in collaboration with study project teams.

    Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases.

    Conduct in-house and site (if applicable) reviews of associated documents to ensure all essential clinical Trial Master File documents are compliant with Good Documentation Practices, Healgen internal SOPs, and US regulations.

    Assist in reviewing clinical protocols and Institutional Review Board (IRB) submissions.
    Manage trial master files, budgets, and agreements for assigned studies.
    Assist with the development of study databases for managing clinical data.
    Partner with cross-functional team (e.g., clinical data management) with query management, data reviews and resolution.
    Maintain accurate and up-to-date clinical trial documentation and assist in analyzing and reviewing clinical data and reports.
    Prepare reports for study initiation, monitoring, and close-out visits.
    Sample acquisition and sample banking for analytical and clinical studies.
    Perform tasks for your level and provide coaching and instructions for the levels below.

    A bachelors degree in health care or other scientific discipline is required.

    0-3 years of relevant experience in clinical affairs, clinical research, or a related field (experience with in vitro diagnostic devices preferred).

    Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

    Basic working knowledge of IRB guidelines and Common Rule.
    Demonstrated experience applying clinical research regulatory requirements, such as Good Clinical Practice, International Conference on Harmonization, and HIPAA guidelines.
    Possesses strong written and verbal communication and presentation skills.
    Strong research, analytical, critical thinking, and problem-solving skills.
    Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
    PC/Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience is a plus).
    Basic understanding of U.S. Food and Drug Administration laws and guidance on clinical studies.
    Knowledge in basic statistical analysis.
    Effective interpersonal skills.

    Please note this position is office.

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