Clinical Research Associate - Oncology
The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) 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 to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
Your responsabilities will include:
- Allocation, initiation and conduct of trials
- Conducting site selection for potential sites to evaluate their capabilities for conducting a clinical trial and recommending sites to participate in clinical trial
- Being the frontline liaison between our customer and sites to ensure successful collaboration, meeting our customer's expectation on milestone and deliveries
- Managing assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and procedures
- Performing Site Initiation Visit, ensuring site personnel is fully trained on all trial related aspects. Performing continuous training for amendments and new site personnel as required.
- Conducting continuous monitoring activities (onsite and remote). Implementing site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
- Being accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
- Ensuring that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Performing Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
- Attending onboarding-, disease indication and project specific training and general CRA training as required
- Documents monitoring activities appropriately
- Collaborating with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed
- Participating from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.
- University Degree in scientific or healthcare discipline.
- Fluent in both written and spoken English and Dutch
- Minimum 2 years of experience CRA
- Good knowledge of drug development process specifically clinical trial/research
- Knowledge of international standards (GCP/ICH, FDA, EMEA)
- 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