Clinical Study Associate

Há 1 mês


Lisboa, Lisboa, Portugal Syneos Health Tempo inteiro
Clinical Study Associate

Syneos Health is seeking a highly skilled Clinical Study Associate to join our team. As a Clinical Study Associate, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities and close-out visits. You will ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.

Key Responsibilities:
  • Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits.
  • Ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
  • Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
Requirements:
  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
  • 2 years (or more) of experience as Clinical Research Associate.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Excellent communication, presentation and interpersonal skills.
Site Management Associate

Syneos Health is a leading biopharmaceutical solutions organization built to accelerate customer success. We are seeking a Site Management Associate to join our team. As a Site Management Associate, you will be responsible for site support throughout the study lifecycle from site identification through close-out.

Key Responsibilities:
  • Site support throughout the study lifecycle from site identification through close-out.
  • Knowledge of local requirements for real world late phase study designs.
  • Chart abstraction activities and data collection.
  • Collaboration with Sponsor affiliates, medical science liaisons and local country staff.
Requirements:
  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
  • 2 years (or more) of experience as Clinical Research Associate.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Excellent communication, presentation and interpersonal skills.


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