Reporting Relationships
The Clinical Research Associate functionally reports to the ProjectManager for project specific responsibilities. The position may bementore******** guide******** Senior Clinical Research Associates. Theposition may also direct tasks of an allocate******** Trials Assistant.The Clinical Research Associate will be instrumental in developingeffective working relationships with the program’s study site staff.
Duties an******** Responsibilities
Study Design
• Coordinate the ******** feasibility assessment an******** ofinvestigators an******** to undertake the study
• Prepare, plan, organise an******** pre-study (site selection) visitsan******** on these visits to assist in site selection
• Prepare for, plan, organise an******** site initiation visits
• Assist in the development of appropriate monitoring tools
• Motivate an******** investigators an******** that the study sitepersonnel have a goo******** of the protocol, an******** requirements ofthe study an******** they can fulfil their obligations to conduct thestudy accurately an******** deadlines.
Study Execution
• Motivate investigators an******** that the study site personnel enrolthe target number of eligible subjects within timeline
• Monitor study by v******** email an******** to the participatingcentres to ensure:
• Verify ******** complet******** an******** of data.
• Completely an******** resolve data an******** queries an********.
• Adhere to the study protocol an******** procedures manual.
• Adhere to ICH/GCP an******** regulatory guidelines an******** asrelevant to this trial including reporting of adverse even********adverse events are reported
• Complete all monitoring visit an******** reports accurately an********the predetermine********.
• Collect an******** essential documents from study sites an********they are appropriately stored/manage********-house.
• Assist participating centre research staff in the local management ofthe study where required.
• Maintain study information using the clinical trial management system.
General
• Manage effective communication with the key stakeholders (outsideven******** Research Coor******** etc).
As a Team Member:
• Participate in team meetings an********
• Participate in objective setting an******** management
• Participate in special projects to improve processes, tools, systemsan******** of GI China
Occupational Health an********
• Comply with OH&S legislation an******** in accordance withestablishe********&S practice an******** at The George Institute
• Promote an******** to a safe, secure environment for staff an********
Sk******** Knowle******** an********
Education/ Research Background
• Tertiary qualifications in a relate******** or health care ********research backgroun******** post-graduate qualifications preferred.
• 2 years experience in clinical operation within an aca******** CRO orpharmaceutical environment.
• Understanding of medical terminology
• Excellent working knowledge of ICH/GCP, ethical an********requirements
• Excellent interpersonal sk******** presentation skills an********ability to work well an******** ie autonomously, in teams an******** awide range of varying stakeholders
• Excellent organisational skills – ability to organ******** takeinitiative an******** up independently
General
• Excellent interpersonal sk******** presentation skills an********ability to work well an******** ie autonomously, in teams an******** awide range of varying stakeholders
• Excellent organisational skills – ability to organ******** takeinitiative an******** up ******** Familiarity with computer systemsparticularly MS Word, PowerPoint & Excel
• Ability an******** to travel on a regular basis
• Ability to see the big p******** yet still focus on detail an********of work
• Ability to be flexible an******** in the face of changingorganisational priorities an******** environments.