Senior Clinical Research Operations Specialist

1 day ago

City of Greater Geelong, Australia beBeeClinicalResearch Full time $114,553 - $129,134
Job Opportunity

This is a challenging position for a professional who can assess clinical study site qualifications, implement studies at participating sites, and manage site conduct.

Responsibilities
  • Evaluate, initiate, monitor, and close clinical study sites.
  • Ensure site conduct adheres to protocols, GCP regulations, International Harmonization Guidelines, company SOPs, and applicable regulatory requirements.
  • Train/re-train site personnel on protocols, systems, and operational aspects of trials.
  • Serve as primary contact for site personnel and sponsor study team members.
  • Develop patient recruitment strategies with clinical sites to meet enrollment timelines.
  • Protect subjects' rights, safety, and well-being.
  • Ensure compliance with adverse event procedures.
  • Evaluate data quality and integrity, ensuring timely resolution of queries.
  • Assist Data Management in developing eCRFs and eCRF Completion Guidelines.
  • Identify and resolve site performance, quality, or compliance issues.
  • Communicate with Investigators, site staff, Sponsor Study Team Members, and QA on protocol conduct, subject recruitment, and overall site performance.
  • Maintain audit-ready trial documentation.
  • Collect, review, and file required regulatory documentation during study maintenance and closeout.
Requirements
  • Bachelor's degree in Life Sciences or RN preferred.
  • Minimum 5+ years of pharmaceutical/biotechnology industry experience as a Clinical Research Associate from start-up to database lock.
  • Strong Oncology monitoring experience in phase 1-3 pharmaceutical/biotechnology clinical trials.
  • High level of monitoring skill with independent judgment.
  • Excellent understanding of ICH guidelines, GCP, PhRMA code, FDA CFR, clinical research ethics, HIPAA, and local regulatory requirements.
  • Strong knowledge of clinical research concepts and drug development.
  • EDC, IVRS, and CTMS system proficiency.
  • Microsoft Office skills.
  • Ability to work independently across multiple studies, projects, and sites.
  • Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills.

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