Senior Clinical Trials Professional

2 days ago

Melbourne, Victoria, Australia beBeeClinical Full time $120,000 - $170,000

Clinical Research Associate Position Overview

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As a Clinical Research Associate, you will be working with the world's largest and most comprehensive clinical research organization.

Job Description
  • Implement and monitor clinical trials to ensure sponsor and investigator obligations are met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
  • Assess the qualification of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
  • Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budget negotiations.
  • Review and verify accuracy of clinical trial data collected, either onsite or remotely.
  • Provide regular site status information to team members, trial management, and update trial management tools.
  • Complete monitoring activity documents as required by sponsor's SOPs.
  • Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
  • Escalate site and trial-related issues per Sponsor's SOPs until identified issues are resolved or closed.
  • Perform essential document site file reconciliation.
  • Perform source document verification and query resolution.
  • Assess investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
  • Verify serious adverse event (SAE) reporting according to trial specifications and ICH GCP guidelines.
  • Communicate with investigative sites.
  • Update applicable tracking systems.
  • Ensure all required training is completed and documented.
  • May be assigned to complex studies and/or sites.
  • Provide leadership skills to assigned projects within the clinical operations department.
Requirements and Qualifications
  • A dedicated clinical research professional with an undergraduate degree in a clinical, scientific, or health-related field from an accredited institution — or equivalent relevant experience. A licensed healthcare professional (e.g., RN) is also acceptable.
  • An experienced Clinical Research Associate with 2-5 years of clinical monitoring experience, including at least 1-2 years of on-site monitoring (vs all remote monitoring).
  • Located near a major hub, with the ability to travel up to 50% of the time.
  • Experienced monitoring oncology trials; SCLC or NSCLC experience preferred but not required.
  • Proficient in feasibility assessments, site selection, and site start-up activities.
  • Familiar with or experienced in Phase 1 dose escalation studies (preferred).
  • Comfortable supporting budget negotiations and resolving site-level challenges (preferred).
  • Highly proactive, detail-oriented, and collaborative — a team player who takes initiative and communicates effectively.
  • Well-versed in ICH-GCP guidelines and applicable local regulatory requirements.
  • Able to lead observation and performance monitoring visits and act as a resource across functional teams to ensure study progress.
  • Skilled in managing tasks that require advanced negotiation and problem-solving.
  • Fluent in spoken and written English.
  • Legally authorized to work in the specified country without requiring current or future employment visa sponsorship.

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