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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.

Ref AS-028440

Het profiel / Your profile

Job Requirements

Bachelor Degree
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

Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.




Geplaatst op FMF: 05 maart 2019

Branche: Farma & Biotech
Functie: Clinical research
Opleidingsniveau: HBO / BSc, WO/academisch / MSc
Werkervaring: 2-5 jaar, 5-10 jaar, > 10 jaar