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