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Biosample Operations Associate Job

Eingestellt von Yoh

Gesuchte Skills: Design, Client

Projektbeschreibung

BIOSAMPLE OPERATIONS ASSOCIATE needed for a contract opportunity with Yoh's client located in South San Francisco, CA

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Organizes and leads cross-functional Sample Pre-initiation Meetings (SPIM) with Clinical Sample Operations (CSO) and drives the decision-making process
- Materials Supply Team to agree to options, design and schedule of materials supply to meet requirements of investigator sites and to aid delivery of overall objectives of bio-sampling in study
- Preparation and maintenance of data reconciliation reports in accordance with project and global standards

WHAT YOU'LL BE DOING:

- The Biosample Operations Associate (BOA) is the logistical, planning and tracking coordinator role supporting and interfacing directly with Biosample Operations Managers (BOMs) on one or more clinical studies simultaneously.
- The BOA performs these activities in collaboration with business partners including the SMT, Clinical Sample Operations (CSO), Study Monitors, Data Management and external CRO partners to ensure that sample material supplies are ordered and delivered and biosamples are fully accounted for, tracked and reconciled.
- Participates in the planning and execution of sample collection, kit design, and sample shipping timeline activities with cross-functional teams and external CRO partners Coordinates and tracks the process of global material supply, interfacing directly with CSO or external CRO partners
- Ensures sample collection information on the CRF/eCRF, where appropriate, matches the protocol requirements Ensures CRF/eCRF informed consent information is linked to samples and is reconciled prior to shipment for analysis, where appropriate
- Works in partnership with the BOM, external labs and CROs, where necessary, to ensure quality sample tracking and reconciliation processes are in place and roles and responsibilities for sample reconciliation are agreed
- Communicates issues with sample quality to monitors and/or investigator sites in a timely manner and ensures that appropriate action is taken by Clinical Sample Operations (CSO) and or external CRO partners
- Communicates and addresses discrepancies and issues with sample collection information to the monitor, site, SMT and BOM in a timely manner and ensures appropriate action is taken to resolve the issue or discrepancy
- Ensures that samples are managed appropriately in CSO to enable efficient selection for shipments to labs
- Confirms that investigator sites and/or Central Labs send samples according to agreed stability shipping schedule for the study and to follow-up to ensure that corrective action where this is not the case
- Ensure sample shipment requests are made and shipments from the CSO or Central Lab to assay labs are processed according to the agreed study schedule
- Maintains oversight for biosample operational activities for agreed samples and provides regular reports, including metrics to the BOM
- Maintains professional knowledge of current GCP, biobanking, and sample management processes and guidelines

WHAT YOU NEED TO BRING TO THE TABLE:

- Clinical development experience of working in teams running clinical studies, monitoring clinical studies or experience working in clinical studies at an investigator site
- Detail oriented with the ability to work independently and manage multiple competing priorities
- Ability to work successfully under pressure
- Planning, organizational and time management skills
- Ability to successfully achieve results within a multi-cultural and geographically diverse team
- Effective influencing skills
- Ability to build and maintain effective working relationships
- Experience in the pharmaceutical industry or similar
- Extensive computer, spreadsheet and database skills

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Bachelor's degree with ideally a minimum of two (2) years of experience in clinical research or health care related industry, or equivalent combination of education and experience
- Life sciences degree or nursing equivalent is preferred, but not mandatory

RECRUITER: Robert West

Yoh, a DayJ2W: SCIENTIFIC

MONJOBJ2WSWSCI

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    South San Francisco, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung, Medien/Design

  • Skills:

    design, client

Yoh