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    Clinical Conduct - Doral, United States - Quotient Sciences Limited

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    Description
    Clinical Conduct - Clinical Laboratory Lead

    Miami, FL, USA

    Req #140
    Thursday, March 28, 2024

    Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway.

    Cutting through silos across a range of drug development capabilities, we helpbiotech and pharma customers save precious time and money in getting drugs to patients.


    As a growing and successful business, we employ more than 1,100talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

    Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.

    People join Quotient Sciences because we are a respected member of the drug development communitythat's focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures,

    fast. Because humanity needs solutions, fast.
    The Role
    Overall responsibility for quality of laboratory processing for assigned duties
    To ensure study data is collected to a high quality in accordance with ICH-GCP, protocol and lab manual
    To ensure subject safety at all times
    Main tasks and responsibilities
    Provides encouragement, support, positive reinforcement to laboratory technicians
    Oversees sample labelling, processing and shipping duties as required
    Ensures lab set up and cleaning duties are performed on a daily, weekly and monthly basis
    Processes biological samples as per lab manual when required
    Attends all pre-study meetings, including SIVs and protocol trainings for assigned studies
    Reviews/Approves lab manual prior to the start of a study
    Ensures sample shipments are organized and sent to clients as per the lab manual and study timeline
    Ensures sample shipment checklists and sample manifests are generated and reviewed for all sample shipments
    Performs sample processing checks on all studies to ensure compliance with lab manual and SOPs
    Ensures the QC of laboratory source data and performs QC as necessary
    Works in a safe and responsible manner at all times
    Reviews protocol specimen processing requirements and ensures that an adequate inventory of necessary supplies are available or ordered and delivered prior to study start and throughout study conduct
    Reviews/approves specimen labels prior to tube preparation
    Ensures collection tubes and freezer vials are properly labelled and set up prior to scheduled sample collection
    Processes samples and assists with laboratory duties as needed
    Assists with SOP reviews and edits
    Works with Data Entry team to resolve discrepancies/queries noted during lab tracking or monitoring visits
    Assists with training of new laboratory staff and ensures lab staff are fully trained and signed off in the relevant SOP/competency and protocols before working unsupervised or on a study
    Additional Tasks/responsibilities
    May serve as a backup to the Clinical Laboratory Manager when required
    The Candidate
    Education or equivalent experience in a science, health or customer related field
    Supervisory experience preferred
    We are an Equal Employment Opportunity ("EEO") Employer.


    It has been and will continue to be a fundamental policy of Quotient Sciences not to discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.


    This policy applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

    #J-18808-Ljbffr


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