Syneos Health

Sr CRA I - Israel

Salary
On Application
Posted
28 Dec 2018
Closes
28 Jan 2019
Ref
18010428

JOB RESPONSIBILITIES

·        Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.  Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.  Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

·        Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

QUALIFICATION REQUIREMENTS  

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Fluent English and Hebrew
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.
  • Ability to manage required travel of up to 75% on a regular basis