Site Activation Specialist - CRO

4 days left

Company
Volt
Location
Amsterdam, Provincie Noord-Holland, NL
Salary
Competitive
Posted
04 Feb 2021
Closes
06 Mar 2021
Ref
MDhB5ZGxio7A
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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

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