Site Activation Specialist - CRO
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Location
Amsterdam
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Sector:
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Salary:
€50000 - €70000 per annum
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Contact:
Carlos Biggemann
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Contact email:
Carlos.Biggemann@volt.eu.com
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Job ref:
77904-PHARM-CBG_1612258164
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Published:
about 3 years ago
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Duration:
permanent
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Expiry date:
2021-04-03
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Startdate:
ASAP
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Consultant:
ConsultantDrop
*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