Děkujeme za pochopení.
Zobrazit podobné nabídky
Senior Clinical Research Associate - CNS - Slovakia
Job description, responsibilities and duties
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
Information about the selection process
English - advanced
Brief description of the company
emedcareers is a niche job site for the European Biopharmaceutical and Medtech industries; providing job opportunities in the development and marketing of medicines and medical equipment.
emedcareers is part of the Jobsite Group of recruitment websites, which has unrivalled experience of online recruitment in the UK and a growing presence internationally. The Jobsite Group itself is part of the Daily Mail and General Trust (DMGT), a highly successful media company operating in over 40 countries worldwide.
emedcareers offers a unique combination of resources and experience to provide the most effective means of developing your careers or securing your first job within the Biopharmaceutical or Medtech industry.