1 week ago

Senior Clinical Research Associate - Sponsor dedicated - Netherlands - Home based

IQVIA

Amsterdam

1 week ago

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IQVIA seeks a Senior Clinical Research Associate for a sponsor-dedicated, home-based role in the Netherlands. The role involves performing site monitoring visits, managing study progress, and ensuring GCP/ICH compliance. Requires 3+ years of on-site monitoring experience, fluency in Dutch and English, and a Bachelor's degree in a scientific or healthcare discipline.

RemoteFull-timeSeniorClinical ResearchGood Clinical Practice (GCP)

Senior Clinical Research Associate - Sponsor dedicated - Netherlands - Home based

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RemoteFull-timeSeniorClinical Research

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

Experience Required

3 years

Employment Type

Full-time

Experience Level

Senior

Core Qualifications

Technical (Must-have)

Clinical ResearchGood Clinical Practice (GCP)ICH GuidelinesSite MonitoringRegulatory SubmissionsCase Report Form (CRF)Trial Master File (TMF)Investigator Site File (ISF)Recruitment TrackingMedical WritingProtocol TrainingProblem SolvingCross-Cultural CommunicationInterpersonal Skills

Soft Skills

Organizational skillsProblem-solving skillsInterpersonal skillsCross-cultural communicationCollaborative mindset

Key Responsibilities

•Perform site monitoring visits (selection, initiation, monitoring, close-out) in accordance with contracted scope and regulatory requirements (GCP/ICH).
•Work with sites to adapt, drive, and track subject recruitment plan in line with project needs.
•Administer protocol and related study training to assigned sites; establish regular lines of communication.
•Evaluate quality and integrity of study site practices; escalate quality issues as appropriate.
•Manage progress of assigned studies by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
•Ensure site documents are available for TMF; verify Investigator Site File maintenance per GCP/local regulations.
•Create and maintain documentation regarding site management and monitoring findings via visit reports and follow-up letters.
•Collaborate with study team members for project execution support.
•If applicable, support development of project subject recruitment plan on a per site basis.

Clinical ResearchSenior CRANetherlandsRemoteSponsor DedicatedIQVIAGCPICHSite MonitoringFull-time

Core Qualifications

Technical (Must-have)

Soft Skills

Organizational skillsProblem-solving skillsInterpersonal skillsCross-cultural communicationCollaborative mindset

Key Responsibilities

•Perform site monitoring visits (selection, initiation, monitoring, close-out) in accordance with contracted scope and regulatory requirements (GCP/ICH).

•Work with sites to adapt, drive, and track subject recruitment plan in line with project needs.

•Administer protocol and related study training to assigned sites; establish regular lines of communication.

•Evaluate quality and integrity of study site practices; escalate quality issues as appropriate.

•Manage progress of assigned studies by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.

•Ensure site documents are available for TMF; verify Investigator Site File maintenance per GCP/local regulations.

•Create and maintain documentation regarding site management and monitoring findings via visit reports and follow-up letters.

•Collaborate with study team members for project execution support.

•If applicable, support development of project subject recruitment plan on a per site basis.