Syneos Health

Sr CRA/CRA II - Home-Based - Single Sponsor, Austria

Location
Austria
Salary
competetive
Posted
14 Jan 2021
Closes
13 Feb 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Here at Syneos Health we are currently recruiting for a  (Senior) Clinical Research Associate in Austria to be home-based. This is an excellent permanent opportunity where one can develop their skill set further and work on exciting clinical studies for one sponsor. 

JOB SUMMARY

The Clinical Research Associate I (CRA I) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.  Performs all tasks routinely and independently.  May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a project or assessor of peers for sign-off visit purposes (as approved).

Your main responsibilities:  

  • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmaco-epidemiology Practice (GPP) and protocol compliance. 
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
  • May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timelines and completeness.
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. 
  • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. 
  • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. 
  • Participates in global clinical monitoring/project staff meetings/ bid defense meetings  (inclusive of Sponsor representation, as applicable).

    Qualifications:

  • Bachelor’s degree or RN in a related field or equivalent combination of education
  • Min. 1 year of experience as a Clinical Research Associate 
  • 3-4 years of experience in the clinical research area
  • Oncology experience required
  • RBM will be an asset
  • 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
  • Fluency in German and English language

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