Clinical Research Associate
The Clinical Research Associate will manage clinical trial sites at every stage of the clinical trial process to a high quality in accordance with the Company’s policies and procedures, relevant legislation and ICH GCP requirements.
- 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 the company, act as an ambassador and contributes to making the company 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.
- Bachelor's Degree level, life science or nursing qualification or equivalent (desirable)
- Basic GCP qualification
- Very good knowledge of French and English
- 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
- Healthcare industry experience or customer service based employment
- Previous experience of monitoring trials in accordance with ICH GCP methodology
- An attractive salary in line with your experience and skills
- Fringe benefits including a company car, medical insurance, pension plan and a care plan
- A supporting environment
- Respect for the life-work balance
- Career planning
- A focus on professional and personal growth through training and coaching
- Room for personal engagement to help shape our company's future