Global Study Associate Job

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

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Global Study Management Team (SMT)
- Clinical Study/Trial
- ICH/GCP

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, 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.
- 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 ideally with 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 Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

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