Site Activation Specialist - CRO

  • Location

    Amsterdam, North Holland

  • Sector:

    Life Sciences

  • Job type:

    Blijvend

  • Salary:

    €50000 - €70000 per annum

  • Contact:

    Carlos Biggemann

  • Contact email:

    Carlos.Biggemann@volt.eu.com

  • Job ref:

    77904-PHARM-CBG_1612258164

  • Published:

    2 maanden geleden

  • Duration:

    permanent

  • Expiry date:

    2021-04-03

  • Startdate:

    ASAP

Responsibilities:
*Main line of communication with potential sites, investigators and study (start-up) teams
*Perform feasibilities post-award and if business requires supports pre-award feasibilities
*Create lists of potential investigators and sites
*Develop feasibility questionnaires
*Initiate contact and relationship with investigators and sites
*Perform pre-study visits (PSV)
*Assess sites' and investigators' suitability
*Discuss and negotiate different types of contracts (incl. budget) with sites, investigators and third parties
*Collect essential (site) documents
*Support management of regulatory (site specific) requirements
*Organize hand-over of sites prior to Site Initiation Visit (SIV)

Qualifications:
*Life science, healthcare and/or business degree
*Minimum 3 years of relevant work experience
*Minimum 3 years of experience in drug development and/or clinical research
*Good understanding of site management and monitoring, preferably through CRA experience.
*Good knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and/or applicable local regulatory requirements