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Senior Clinical Research Associate - CNS - Slovakia

Senior Clinical Research Associate/CNS - Slovakia

PharmaNet/i3 is recognized as a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, including therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and staffing from a single clinical professional to an entire functional team. For intelligent solutions needed to accelerate high quality drug development programs of all sizes around the world, PharmaNet/i3 works for you.

The Senior Clinical Research Associate/CNS performs routine site visits to ensure the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), SOPs, GCP/ICH Guidelines, and other applicable regulatory requirements. Additionally, the Senior Clinical Research Associate/CNS assists in training and mentoring other regional monitoring personnel.

Main tasks include:
* Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Visits include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements and assurance of good site performance.
* Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
* Report to PharmaNet/i3 project team, client, and site personnel any findings noted at monitoring visits.
* Maintain eClinical or alternative project tracking system of subject and site information.
* Serve as back-up for Regional Manager, Clinical Operations when required.
* Provide training for colleagues on clinical, regulatory, administrative, and company procedures and processes.
* Participate in feasibility studies.
* Assist with company's quality control initiative.
* Present study materials at Investigator/study launch meetings when required.

Minimum requirements are:
* Bachelor's level degree in life sciences, pharmacy, nursing or RN preferred
* Experience in monitoring CNS trials is essential!!
* Five + years clinical monitoring experience
* Strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
* Proven ability to work independently in a fast-paced environment
* Strong communication, interpersonal, and organizational skills
* Must demonstrate good computer skills
* Ability to provide clear direction and guidance to others.

We offer a very competitive salary package and a great opportunity to develop further in an international, growing environment.

Please contact Thomas Gl
ID: 1296012   Datum zveřejnění: 17.7.2012
Společnost: emedcareers

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