Clinical Research Associate

2 weeks ago

Sydney, New South Wales, Australia Pharmiweb Full time
Job Title: Clinical Research Associate

We are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for conducting site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key Responsibilities:
  • Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, 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.
  • Conduct Source Document Review of appropriate site source documents and medical records.
  • Verify required clinical data entered in the case report form (CRF) is accurate and complete.
  • Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
Requirements:
  • 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.
  • Ability to manage required travel of up to 75% on a regular basis.
About Us:

At Syneos Health, we are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to 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 not only make Syneos Health easier to work with, but to make us 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 to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

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