This job is currently Archived,
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 science)" rel="nofollow">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 science)" rel="nofollow">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, sciences" rel="nofollow">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
Find a Job Find Candidates