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Clinical Research Associate - Netherlands
SMS Oncology (company)
Posted on : 10 April 2017
Clinical Research Associate
- The CRA is responsible for ensuring that investigational sites perform clinical studies according to the study protocol and in compliance with SOPs, applicable regulations and the principles of Good Clinical Practice.
- He or she will act as the main line of communication between the sponsor and the investigator and will perform regular monitoring visits.
- Moreover, he or she will assist in identifying, selecting and initiating investigational sites.
Roles and responsibilities
- Identifying and recruiting investigational sites
- Performing selection visits
- Assisting in the preparation of regulatory submission packages and obtaining approval from investigational sites
- Performing initiation visits
- Performing monitoring visits to verify that source data/documents and other trial records are accurate, complete, and maintained
- Verifying patient eligibility and communicate document protocol violations and non-compliance
- Verifying whether Serious Adverse Events are reported according to safety regulations
- Checking drug accountability and handling at the investigational sites
- Acting as the main line of communication between the sponsor and the investigator
- Preparation and maintenance of all necessary study files and documentation
- Ensuring that investigators achieve their patient recruitment targets
- Liaising with the project manager to ensure he/she is kept informed about study progress at the sites
- Preparation of monitoring visit reports
- Ensuring a timely and accurate resolution of data management queries
- Assisting in the performance of feasibility studies
- Supporting site staff in preparation for trial site audits and inspections
- Contributing to other areas of company business as required
Qualifications and characteristics
- Degree in medicine, health care, life sciences or related fields
- In-depth knowledge of Good Clinical Practice (GCP) and local regulations and processes
- Good understanding of the Dutch language
- Fluency in written and spoken English, and French
- In possession of driving license
- Interest in oncology, and preferable 1 year of oncology experience
- Ability to review and evaluate clinical data
- Experience in clinical research preferred
- Good communication skills
- Representative and outgoing
- Administrative excellent
- Self motivated and proactive
- Our mission is to provide Direction to our clients during the entire drug development path from Drug to Data to Dossier (the so-called “4D” concept).
- Becoming our employee allows you to actively contribute to bringing innovative cancer therapies to patients.
- As a fast-growing dynamic company, we offer exciting opportunities to further develop yourself.
- We invest in our employees, want them to be happy and secure in their jobs, and to become autonomous, flexible, oncology experts that deliver high-quality work.