CRA / Dedicated Partnership to international Pharma company
Covance is actively recruiting CRAs to be dedicated to one of our main client, a weel-known pharmaceutical company with offices in Amsterdam and at at the forefrint of Oncology development.
If you want to be part of a dynamic team and work environment offering flexibility, career development perspective and energizing purpose, apply now!
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation
- Prepare accurate and timely trip reports
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
- Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Assist with training, of new employees, e.g. co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
- Valuable Clinical Monitoring experience
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Good planning, organization and problem solving abilities
- Ability to work with minimal supervision
- Good communication and interpersonal skills
- Good analytical and negotiation skills
- Fluent in Dutch and in English, both written and verbal
If you are looking to broaden your therapeutic expertise whilst gaining exposure to a Pharmaceutical working environment this is a fantastic opportunity to seize now!
As an experienced CRA, you will be involved in initiation, routine & close out visits.
Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE.
We are looking forward to hearing from you and welcoming you to Covance!