Senior Clinical Research Associate
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plaats
Florida
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Sectoren:
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soort baan:
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salaris:
Negotiable
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Contact:
Carlos Biggemann
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Contact email:
Carlos.Biggemann@volt.eu.com
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functie ref:
BBBH10881_1658326599
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gepubliceerd:
bijna 2 jaar geleden
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Vervaldatum:
2022-08-19
Conducting site visits, including pre-study, initiation, monitoring and termination;
Confirming adherence to all FDA, ICH-GCP and local regulations;
Ensuring the completion and collection of regulatory documents;
Performing data verification of source documents;
Ensuring implementation and compliance with FDA, ICH-GCP guidelines;
Participating in budget negotiation and follow-up where applicable;
Assisting with data validation and query resolution;
Mentoring junior team members as required.
Qualifications:
· An advanced level of oncology knowledge
· Minimum 2 years CRA experience
· Completion of a science-related Bachelor's degree
· Excellent knowledge of medical terminology and clinical monitoring process
· Strong ICH-GCPs knowledge
· Experience with clinical trial information systems
· Ability to travel up to 60% on average