Clinical Research Associate, Biotech (On-site)
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De functie
Serve as a dedicated Clinical Research Associate responsible for on-site monitoring of oncology solid tumor trials, ensuring protocol and regulatory compliance.
Perform site visits (selection, initiation, monitoring, close-out) per scope of work and ICH/GCP guidelines.
Collaborate with site staff to drive subject recruitment, deliver protocol training, and maintain clear communications to manage expectations.
Track study progress through regulatory submissions, enrollment, CRF completion, and data query resolution to protect data integrity.
Maintain essential documentation in TMF and ISF and support cross-functional teams on study execution and budgeting tasks.
Bachelor's degree in life sciences or related field with at least 1 year of on-site monitoring experience and ability to travel.
Perform site visits (selection, initiation, monitoring, close-out) per scope of work and ICH/GCP guidelines.
Collaborate with site staff to drive subject recruitment, deliver protocol training, and maintain clear communications to manage expectations.
Track study progress through regulatory submissions, enrollment, CRF completion, and data query resolution to protect data integrity.
Maintain essential documentation in TMF and ISF and support cross-functional teams on study execution and budgeting tasks.
Bachelor's degree in life sciences or related field with at least 1 year of on-site monitoring experience and ability to travel.
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