Junior/Medior Clinical Research Associate
The main function of a clinical research associate (CRA) is to monitor clinical trials and ensure that clinical trials adhere to established guidelines, regulations and Standard Operating Procedures (SOP’s): i.e., ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs), and communicates with clinical research coordinators.
The CRA will be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial.
- Contribute to the identification of new sites for clinical trials; analyze capability and support Clinical Research Medical Advisor (CRMA) and Clinical Study Manager (CSM) in making recommendation for trial inclusion
- Assume ambassadorial role to facilitate communication between sites and Novartis CPO to increase value proposition to investigators
- Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP
- Ensure adherence to payment schedule
- Execute site initiation and training, generate initiation visit report
- Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes
- Identify problems at sites; resolve issues and escalate as appropriate
- Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed
- Complete preparation and generation of visit monitoring reports as per relevant SOP
- Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets
- If working with central CRAs (blinded and unblinded), respond to alerts and follow-up to ensure resolution of issues
- Implement site close-out activities and generate site close-out report
- Provide feedback on site performance for future trial site feasibility/selection”
- Medical or Scientific background or equivalent through experience
- 1-3 years monitoring experience
- Proactive dynamic self-starter who values efficiency and process improvement
- Strong team player with excellent communication skills and an open communications style
- Fluent English, Dutch and French
- 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.