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Senior Clinical Research Associate Amsterdam Netherlands,
SMS Oncology (company)
Posted on : 10 April 2017
Senior Clinical Research Associate
- The senior Clinical Research Associate (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 acts as the main line of communication between the project manager and the investigator and will perform regular monitoring visits.
- Moreover, he or she will assist in identifying, selecting and initiating investigational sites.
Role 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
- Providing input on study related documents
- 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
- Preparation and maintenance of all necessary study files and documentation
- Helping that investigators achieve their patient recruitment targets
- Liaising with the project manager to ensure he/she is kept informed
- 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
- Participation in the training of new Clinical Research staff
- Performing co-monitoring visits
- Contributing to other areas of company business as required
Qualifications and Characteristics of the Ideal Candidate
- Degree in medicine, health care, life sciences or related fields
- In-depth knowledge of Good Clinical Practice (GCP) and local regulations and processes
- At least 2 years of monitoring/CRA experience
- Experience with coordinating other CRAs or leading a team
- Excellent organization and management skills
- Understanding of the Dutch language
- Fluency in written and spoken English
- Foreign language skills preferred
- In possession of driving license
- Interest in oncology
- Good communication skills
- Representative and outgoing
- Administrative excellence
- 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.
1098 XH Amsterdam The Netherlands
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