Avania are hiring for the key role of Senior Clinical Research Associate (CRA) and Field Clinical Specialist (FCS)
As a Senior Clinical Research Associate (CRA) you will:
• Be responsible for the start-up and initiation of Clinical Investigations including application processes to ethics committees and national competent authorities, preparation and conduct of site monitoring, site management and close out activities.
• Be the study lead for several studies
• Act as main point of contact for the sponsor
• Manage small clinical Investigations independently
• Ensure coordination of a larger Clinical Investigations in collaboration with jr. and sr. CRAs and contractors together with a Project Manager
• Train study sites on performing Clinical Investigations
• Identify problems and risks that interfere with project progress, implement strategies to resolve issues in cooperation of a Project Manager. Work on site-level to ensure timely resolution of issues found during visits.
• Organize... and actively participate in sponsor, investigator and project meetings.
• Provide consistent reports and updates to all team members and management (in team meetings) by keeping the Project Manager informed and assist Project Manager in managing the project
• Mentor study specific monitoring team, coordinate monitoring activities and conduct co-monitoring or training visits.
• Be involved in Task Forces and may obtain special initiatives such as acting as a ‘Subject Matter Expert’
The Field Clinical Specialist element of the role will involve;
The role of the Field Clinical Specialist (FCS) is to provide clinical based support of pre and post market clinical studies including but not limited to serving as a clinical/technical resource for Clients and clinical sites. This role requires excellent multi-level communication skills, an ability to communicate well and be sensitive to investigational participants, as well as establishing and maintaining a good relationship with study investigators and investigational sites. The position involves close and regular communication with Project Managers, other Clinical Research Associates, site sta and Clients in order to provide timely and accurate reporting of clinical events at sites.
The role requires the ability to achieve excellent technical knowledge in a number of clinical areas. The FCS will be responsible for acting as the Client representative in following prescribed Instructions for Use and supporting clinicians during implantation and product related procedures in operating rooms and interventional radiology suites. In a support capacity, this role supports Clients’ research and development in evaluating concepts for new products, and the improvement/modications of existing system(s
Australia