Senior Clinical Research Associate

Senior Clinical Research Associate

Syneos Health

Home-based, Austria

The Clinical Research Associate I (CRA ) 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. 3 years of experience as a Clinical Research Associate.
  • Oncology experience required.
  • RBM will be preferred.
  • 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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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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