Clinical Research Associate

Contenido de trabajo

We are looking for a CRA who performs monitoring activities related to initiation, conduct and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country.

The CRA is responsible to deliver data within timelines and required quality standard, responsible for adherence tomonitoring procedures in accordance with GCP and ICH, local regulations and SOPs.

Interested in this project? Send your CV + motivation letter to : sarah.leten@professionals.randstad.be

Responsibilities

Major Accountabilities:

Allocation, initiation and conduct of trials

• Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial
• Is the frontline liaison between the company and sites to ensure successful collaboration, meeting the company expectation on milestone and deliveries
• Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and procedures
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate
• Conductscontinuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
• Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
• Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
• Attends onboarding-, disease indication and project specific training and general CRA training as required
• Documents monitoring activities appropriately following standards
• Collaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed
• Participates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
• Performs additional task as assigned

Qualifications

• Degree in scientific or healthcare discipline.
• Fluent in both written and spoken English and Dutch, local language as needed in clusters/countries.
• Min 2 years pharmaceutical industry experience or other relevant experience
• Good knowledge of drug development process specifically clinical trial/research
• Knowledge of international standards (GCP/ICH, FDA, EMEA)
• Monitoring experience is required
• Ability to travel domestically (and occasionally to the Netherlands) as needed to study sites and for training and meetings.
• Good communication skills, ability to influence others.
• Excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders
• Ability to manage sites independently; Proven ability to work independently with minimal supervision
• Ability to anticipate potential issues and take appropriate actions with or without supervision.
• Advanced data accuracy: Ability to work focused with a great attention to detail

Offer

As an answer to your high performance & flexibility, Randstad Professionals offers you aninteresting salary package, with some interesting extras like:

• Meal vouchers of €7
• Net representation cost of €80
• Hospitalization insurance
• Car + unlimited fuel card OR home-work compensation
• 32 holidays
• End-of-year bonus
• Pension plan
• ECO vouchers

Opportunities to follow trainings

And on top of this you’ll improve your skills and become an even bigger expert!