Klinik Araştırma Koordinatörü İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
- University degree from a reputable university, preferably in Chemical Engineering, Pharmacy, Chemistry, Biology or Moleculer Biology
- Preferably minimum 1 year of experience in Clinical Research and Regulatory Affairs in health care industry
- Strong communication skills, planning and organization skills
- Good command of English
- Good knowledge of MS Office applications
- Willingness to work in a dynamic environment
- Good understanding, personal responsibility, and eager to learn
JOB DESCRIPTION
Under the direction of the Regulatory Affairs Manager the incumbent:
- Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Prepare and execute products registration submissions to local authority
- Responsibilities to follow-up of post-approval labeling
- Review promotional materials which are prepared by Marketing department from regulatory point of view
- Keep regulatory documentation in order and updated
- Responsible for regulatory compliance as required by international and local regulations.
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