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Global Study Associate Job

Eingestellt von Yoh

Gesuchte Skills: Support, Affiliate

Projektbeschreibung

GLOBAL STUDY ASSOCIATE needed for a contract opportunity with Yoh's client located in South San Francisco, CA.

What You'll Be Doing:
- Provides logistical support to one or more global study management teams (SMT)
- Develops and maintains effective working relationships with SMT members, affiliate team members, and vendors.
- Assists GSM with effective communication between the SMT and Affiliates.
- Coordinates the management of all global drug supply utilizing the designated systems in collaboration with the GSM.
- Tracks and manages the ordering and distribution of non-clinical supplies throughout the course of the study.
- Coordinates investigator and study coordinator meetings in collaboration with the GSL and GSM.
- Tracks and Maintains Study Information and Documentation and Reports on Study Progress Maintains accurate tracking and reporting of Study Management data.
- Oversees the timely tracking of Health Authority/IRB/IEC submissions and approvals in AIMS/CTMS.
- Identifies any delays and raises issues to the GSM and appropriate CSM.
- Provides IRB/IEC and HA submission documentation and all other supplementary documentation to affiliates or PDR as appropriate.
- Assists in the coordination of activities to ensure CRO and vendor delivery against the contracted scope of work
- Participates in the review of vendor study specific scope of work, guidance documents, and manuals in collaboration with the GSL and GSM.
- Organizes the logistics of the vendor kick off meetings and any subsequent face to face meetings in collaboration with the GSL and GSM.
- Participates as required in vendor meetings.
- Coordinates communication for defined tasks and tracking information between the study team and vendor.
- TMF Management Maintains and ensures the completeness of the Study Level Trial Master File (TMF) in accordance with SOP requirements.
- Identifies and contributes to areas of best practice and process improvements
- Proactively incorporates leanings and recommendations from other study debriefs and best practices.

What You Need to Bring to the Table:
- Bachelor's degree with ideally a minimum of two (2) years of experience in a clinical research or health care related industry, or equivalent combination of education and experience.
- Life sciences degree or nursing equivalent is preferred.
- Knowledge of ICH/GCP
- Experience of working as part of large team with a proven ability to make an active contribution to the team's performance and team working.
- Proven effectiveness with written and verbal communication skills.
- Proficient computer skills across multiple applications
- Prioritizes and multitasks to ensure that tasks are completed on time
- Self-motivated and displays initiative (resourceful) - for instance to move actions forward without the need for continual supervision

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayJ2W: CLINICAL

MONJOB J2WSWSCI

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    South San Francisco, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh