Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld.
Attendeer FMF hierop
Clinical Research Associate NL
Great job opportunity to join an international pharmaceutical company, working as CRA with SSU tasks!
De functie / The role
Roles & Responsibilities of the position
Your primary accountabilities will include:
Successfully implement and execute trials at assigned sites.
Regulatory and SSU activities.
Ensure compliance with regulations, guidelines and policies for studies implemented at assigned sites.
Ensure recruitment strategies in place to meet study needs, including patient enrolment targets at assigned sites.
Monitor site quality and performance (metrics); develop solutions to optimize performance.
Monitor site availability, commitments, infrastructure and capabilities.
Ensure all safety issue are communicated and managed by Principal Investigator and study team in timelines appropriate to the regulatory and protocol requirements.
Develop and implements effective corrective action plans for all quality issues identified at assigned sites.
Actively participate with study team to stay current with study needs, communicating as needed with sites within defined timelines.
Maintain thorough knowledge of country regulations with special focus on regulatory requirements, guidance documents, and standards relating to global clinical trial conduct for medical devices, pharmaceuticals and biologics, and uses that knowledge to enhance site compliance and performance.
Perform all monitoring activities according to protocol monitoring plan and relevant Work instructions.
Build positive relationship with principal investigators and site personnel under their responsibility.
Het profiel / Your profile
Minimum two years of experience in clinical study monitoring
CRA with experience in Study Start Up, Risk Based Monitoring
Supporting Project Manager tasks
Dutch and English speaker
Het aanbod / The offer
We offer a long term collaboration, full time or 0,8FTE and home based role