Remote (City) Full-time

Syneos Health is hiring a FSP- Sr CRAI/ II (Melbourne/ Sydney)

About the Role

Syneos Health is hiring a Senior Clinical Research Associate (CRA I/II) to ensure the quality and compliance of clinical research studies. In this role, you will play a key part in developing monitoring tools and processes while guiding the success of trials through expert collaboration and mentorship.

What You'll Do

  • Conduct on-site and remote monitoring of clinical research studies to ensure compliance with accepted clinical practices and regulations.
  • Develop tools, procedures, and processes, such as monitoring plans and SOPs, to ensure quality oversight.
  • Direct the work of lower-level professionals, including training and mentoring junior staff members.
  • Ensure trials are conducted according to regulatory requirements and company standards.
  • Provide guidance and support to clinical research teams, resolving issues and facilitating communication.
  • Maintain accurate and timely documentation of all monitoring activities.
  • Identify and resolve issues related to clinical trial conduct, including protocol deviations and data discrepancies.
  • Collaborate with cross-functional teams for successful trial execution.

What We're Looking For

  • Bachelor's degree in a related field.
  • Minimum of 5 years of experience in clinical research monitoring.
  • In-depth knowledge of clinical trial processes, regulations, and Good Clinical Practice (GCP) guidelines.
  • Strong analytical, problem-solving, and organizational skills with excellent attention to detail.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team, managing multiple projects and priorities.
  • Proficiency in clinical trial management systems and software.
  • Ability to travel as required for on-site monitoring visits.

Nice to Have

  • Certified Clinical Research Associate (CCRA) or equivalent certification.

Team & Environment

You will direct the work of lower-level professionals, providing mentorship and training. Syneos Health is passionate about developing our people through career progression and training, committed to a 'Total Self' culture where you can authentically be yourself, and dedicated to creating a place where everyone feels like they belong.

Work Mode

This is a local-city based position located in Melbourne or Sydney.

Syneos Health is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Required Skills
Clinical ResearchICH-GCPSite ManagementMonitoringRegulatory ComplianceProtocolSOPsTMFPatient SafetyData IntegrityCommunicationStakeholder Management
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About company
Syneos Health

Syneos Health® is 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.

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Job Details
Category other
Posted 7 months ago