Senior Clinical Research Associate

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Posted 4 weeks ago

Senior Clinical Research Associate

Reports to: Head of Clinical Operations, ANZ

Why you’re here

To manage clinical trial sites to a high quality in accordance with the Company’s policies and procedures, SOP’s, Local Work Instructions (LWI’s), and ICH GCP requirements.

What you’ll deliver

  • Milestones for all assigned studies
  • High-quality relations with key customers and site staff
  • CTMS maintenance per responsible studies
  • Sites compliant with protocol, SOP’s, Local Work Instructions (LWI’s) and ICH GCP
  • Site selection in line with business objectives
  • Project success criteria

How we’ll measure it

  • Milestones achieved
  • Inspection/audit findings against procedures
  • Field visit evaluation, including quality of relationships with internal team and external investigators and sponsors
  • Quality reports from CTMS
  • On-time delivery of assigned clinical studies, with quality standards and within budget
  • Efficient and effective study start-up activities, including Site Evaluation Visits, met within predefined targets

What you’re responsible for

  • Implementing and conducting global or local Phase 1 – 4 clinical studies
  • Conducting site management in accordance with protocol, SOP’s, Local Work Instructions (LWI’s) and ICH-GCP guidelines, including; feasibility, sites selections, obtaining necessary approvals and documentation, site initiations, monitoring and SDV, management of site recruitment performance, trial supplies management, data cleaning activities, close-out and archiving
  • Reviewing and approving site visit reports – including follow up, issue resolution and updating CTMS following every visit
  • Maintaining current knowledge of therapeutic areas, SOP’s and ICH GCP guidelines
  • Managing query resolution processes with sites and the Data Management team
  • Participating in Investigator Meetings
  • Ensuring all Clinical Trial Management Systems and other applicable systems, are maintained
  • Achieving close liaison with Project Management, Clinical Trial Manager, Data Management and HQ throughout the trial to ensure milestones achieved
  • Working alongside Clinical Project Managers in:
  • Planning and leading daily clinical monitoring
  • Facilitating cross functional team and client communication for study problem solving
  • Reviewing the accuracy and quality of clinical management systems
  • Identifying opportunities for improved project training and quality control across the team

Qualifications

  • Life sciences degree or equivalent combination of education, training and relevant industry experience

Work experience

  • Experience in monitoring complex global trials, ideally with a CRO background
  • Working experience in ophthalmology and oncology highly desirable

Technical knowledge & skills or other requirements

  • The role is a progression in responsibility from the Clinical Site Manager
  • Solid understanding of the clinical trial process (including involvement in all periods of the trial), country regulations and guidelines and ICH GCP guidelines
  • Good knowledge of clinical trial methodology, local clinical/health systems and knowledge of cultural/professional practices internationally (desirable)
  • Up to date knowledge of the clinical trials environment – ICH GCP, regulatory issues, SOP’s
  • Knowledge of drug development process
  • Computer literacy and IT skills, good working know­ledge of CTMS
  • Ability to travel locally and/or internationally
  • Valid driver’s licence and passport

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