Global Clinical Studies Manager

2 days ago

Sydney, New South Wales, Australia beBeeClinicalResearch Full time $120,000 - $140,000
Senior Clinical Research Associate Job Description

The primary role of a Senior Clinical Research Associate is to oversee the implementation and conduct of clinical studies at participating sites. This involves assessing site qualifications, managing site conduct, ensuring site performance and quality, and closing out studies.

This position requires strong relationship-building skills, as well as the ability to work efficiently and effectively with internal and external partners. The ideal candidate will have a deep understanding of Good Clinical Practice (GCP), company Standard Operating Procedures (SOPs), and regulatory requirements.

Responsibilities:
  • Evaluate, initiate, monitor, and close clinical study sites, documenting activities in comprehensive Monitoring Visit Reports and Contact Reports.
  • Ensure site conduct aligns with protocol, GCP regulations, International Harmonization Guidelines, company SOPs, and applicable regulatory requirements.
  • Train site personnel on protocol, systems, and operational aspects of the trial.
  • Serve as primary contact for site personnel, liaising between site personnel and sponsor study team members.
  • Develop patient recruitment strategies with the clinical site to meet enrollment timelines.
  • Protect subjects' rights, safety, and well-being.
  • Ensure compliance with procedures for adverse events and serious adverse events.
  • Evaluate data quality and integrity, ensuring sites enter data into Electronic Data Capture (EDC) and resolve queries in a timely fashion.
  • Support data validation and data cleaning procedures to ensure timelines are met.
  • Identify, assess, and resolve site performance, quality, or compliance problems, developing intervention plans as needed.
  • Communicate with Investigators, site staff, Sponsor Study Team Members, and Quality Assurance (QA) on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
  • Maintain audit-ready clinical trial documentation, collecting, reviewing, monitoring, and filing required regulatory documentation during study maintenance and at study closeout.

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