Clinical Trial Coordinator II
On-siteSydney, New South Wales, Australia
Job Summary
Coordinate assigned trial activities by performing file reviews, processing documents for the (e)TMF, and tracking study metrics and findings. Manage site activation by coordinating feasibility assessments, compiling Investigator Site File materials, and maintaining accurate contact details in company systems. Support regulatory compliance by reviewing local documents, assisting with submission packages, and ensuring real-time communication regarding site risks and survey data. Maintain database accuracy, manage project finances, and train new personnel while collaborating with internal teams to meet targeted deadlines. This role requires strong organizational skills, proficiency in clinical trial databases, and knowledge of ICH Good Clinical Practices.
Required Qualifications
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Bachelor's degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years)
- Ability to work in a team or independently, as required
- Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non clinical/clinical aspects of project implementation, execution and closeout
- Excellent English language and grammar skills
- Proficient local language skills as needed
- Good presentation skills
- Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint)
- Ability to obtain knowledge and master all clinical trial database systems
- Must be able to attend the site three days per week during the first six months of employment
Desired Qualifications
- Bachelor's degree preferred
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