Clinical Research Associate - Sydney, Australia - Grand Pacific CRO
3 weeks ago
Description
About Us:
The Grand Pacific CRO team has over 25 years' experience in conducting clinical trials in the Asia Pacific region, including Australia, New Zealand and South Africa. We have continued as a leader in the industry and have expanded services to include central laboratory, site management and image reading services. We pride ourselves on meeting customers where they are and providing exactly what they need to move their products forward.
Job Summary:
Responsible for the successful implementation and conduct of global or local Phase 1-4 clinical studies in line with regulatory requirements, policies and guidelines.
Location:
Key Responsibilities:
- Project managing assigned activities as assigned at the discretion the Head of Clinical Operations
- Monitoring clinical studies (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations. Manage Investigative Sites remotely between visits via telephone calls and other channels of communication
- Mentoring and comonitoring visits with junior, or new, clinical team members
- Planning day to day activities for monitoring of a clinical study and ensure the accurate and timely submission of Monitoring Reports
- Preparing and conduct onsite qualification, study initiation, interim monitoring and closeout monitoring visits at investigator sites
- Escalating issues when appropriate/necessary and provide feedback for the team
- Managing query resolution process with sites and GP CRO's Data Management team
- Completing Country Study feasibilities as directed by GP CRO Management
- Planning and implementing Patient recruitment and retention strategies for assigned clinical studies.
- Actively participating in Investigator Meetings as designated by Chief Scientific Officer/Head of Clinical Operations
- Ensuring adherence to all study timelines for assigned studies
- Preparing and managing the Study Budget for assigned studies
- Ensuring all Clinical Trial Management Systems and other applicable systems are maintained.
- Conducting and implementing other activities such as Study Start Up, Pharmacovigilance, writing of SOP's and Working Instructions, active participation in Team Meetings and sharing and implementing of new innovative ideas within the team.
Work Experience:
- Experience in monitoring complex and/or global trials with a Pharmaceutical or CRO background
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