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Clinical Research Associate

2 weeks ago


Gold Coast, Queensland, Australia Syneos Health, Inc. Full time

At Syneos Health, Inc., we are dedicated to accelerating customer success by translating unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do.

We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with, but also easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives. Discover what our employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most.

Job 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 Pharmacoepidemiology Practice (GPP) compliance.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
  • 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.

Qualifications

  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Excellent communication, presentation, and interpersonal skills.