For one of our clients, a sponsor with an innovating pipeline, we are looking for a Clinical research associate (CRA).
- Do you have previous experience as Clinical research associate or Lead CRA?
- Are you a good communicator, able to express yourself in Dutch, French and English?
- Do you have strong organisational and planning skills?
This position is open for freelance consultants. Fulltime availability is a must.
Don't hesitate to get in touch if you would like to receive more information.
The Clinical Research Associate (CRA) is the primary point of contact between site staff and our client. In this role the CRA acts as ambassador for the company and contributes to making our client the preferred partner.
The CRA is responsible for taking leadership of site management for the initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, company procedures and protocol requirements to ensure data quality and study subject protection. The CRA is responsible for managing the site to meet patient recruitment rate and target. The CRA thereby delivers results that have direct impact on the successful completion of the clinical programme.
- Work within the respective country with one or more clinical trials, representing the local team in the CDC trial team led by the CDC Trial Manager, when applicable
- Primary point of contact between site staff and our client, act as an ambassador for the company and contributes to making our client the preferred partner in clinical trials
- Contribute to or lead selection of sites, in collaboration with CDC and local colleagues such as LM and Medical Affairs
- Overall site management, including site monitoring and remote monitoring as applicable
- Ensure that trial site staff are properly trained to conduct the trial(s), provide necessary training and identify and flag any development areas and implement mitigations
- Managing trial sites to meet patient recruitment and retention target, aimed at successful completion of the clinical programme
- Close collaboration with relevant roles to ensure successful conduct of the trial, such as local Lead CRA, CDC Trial Manager, CDC CTA and local Line Manager
- Ownership of site management and trial conduct and timely flagging of any issues proactively to relevant roles within local team and/or CDC
- Agree on tasks responsibility split and timelines with CDC CTA within the trial, including timely provision of trial documentation
- Contribute to or drive Scientific Recruitment and Retention (SRR) planning and execution, in collaboration with CDC Trial Manager and as agreed with Line Manager
- Perform local administrative tasks as agreed with the Line Manager
- Responsible for site preparedness for audits and inspections and all related follow-up activities
- Other relevant trial, site or documentation related tasks as assigned by line manager
- Represent country in the CDC trial team
- Ensure management and development of clinical sites within country
- Collaboration with CDC Trial Manager and Clinical Trial Administration and other trial CRAs to ensure alignment of clinical operations processes across CDC countries
- Bachelor's Degree level, life science or nursing qualification or equivalent (desirable)
- Knowledge of clinical trial methodology
- Knowledge of the clinical trials environment – ICH GCP, regulatory issues, SOPs
- Knowledge of drug development process
- Good working knowledge of electronic clinical trials systems – IMPACT, EDC, IWRS, electronic TMF
- Computer literacy and IT skills
- Previous experience of monitoring trials in accordance with ICH GCP methodology
- Ability to work in changing environment to be agile and proactively find efficient ways of doing things
- Fluency in French, Dutch and English
015 21 11 04