Clinical Research Associate (38526) Sydney, Australia
Clinical Research Associate
- Work directly for a sponsor
- Carry out monitoring activities across a wide range of trials
- Remote / on-site hybrid role
- Work for a top tier multinational pharmaceutical company
- Close knit and supportive team with great developmental opportunities
- Work on some exciting new product portfolios
- Attractive salary package
About the company
Our client is a market leading pharmaceutical company that are creating some lifesaving medicines that are changing people lives worldwide. This company has a global presence with expanding operations in Australia and New Zealand.
About the Role
The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies, following appropriate documentation, while liaising with the clinical team, site staff and project managers.
- Obtain and maintain essential documentation in compliance with ICH-GCP, procedural documents and local regulations both in the office and at site.
- Initiate, monitor and close study sites in compliance with procedural documents, share information on patient recruitment and study site progress with project managers.
- Train, support and advise investigators and site staff and contribute to team meetings.
- Drive performance at the sites by proactively identifying study-related issues and escalate as appropriate.
- Update database and other systems with data from centres as per study requirements, perform source data verification and ensure data query resolution.
- Manage study supplies, drug supplies and drug accountability at study sites.
- Manage pharmacovigilance and ensure adverse events are reported.
- Assist in audit preparation and regulatory inspections by working with cross functional departments.
- Provide the required monitoring visit reports within required timelines.
- Work with data management to ensure quality of the study data.
- Ensure compliance with company's internal SOP’s, work processes and policies
- University degree in life sciences, or related discipline.
- Full driving license and ability to travel nationally as required.
- Minimum of 18 months local independent monitoring experience.
- Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Pharmaceutical experience, ideally have worked in a sponsor or CRO environment.
- Full Australian working rights.
The company values and rewards accountability, collaboration, and hard work. These values are fundamental to the company and are why they deliver excellent results and create lifesaving medicines helping patients around the globe.