The role of Senior Clinical Research Associate (Sr CRA) is primarily responsible for GreenLight Clinical implementation and conduct of global or local Phase 1 – 4 clinical studies according to local regulatory requirements, policies and guidelines and in line with ICH GCP. The Sr CRA will project manage challenging areas of study to ensure the delivery of data quality within the required study timelines and costs.
- Project management of assigned activities as assigned at the descretion the Clinical Operations Director
- Monitor 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 co-monitoring visits with junior, or new, clinical team members
- Plan day to day activities for monitoring of a clinical study and ensure the accurate and timely submission of Monitoring Reports
- Prepare and conduct on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
- Escalate issues when appropriate/necessary and provide feedback for the team
- Manage query resolution process with sites and GreenLight’s Data Management team
- Complete Country Study feasibilities as directed by GreenLight Management
- Plan and implement Patient recruitment and retention strategies for assigned clinical studies.
- Actively participate in Investigator Meetings as designated by Clinical Operations Director
- Ensure adherence to all study timelines for assigned studies
- Prepare and manage the Study Budget for assigned studies
- Ensure all Clinical Trial Management Systems (eg Siebel CTMS) and other applicable systems, are maintained.
- Conduct and implement 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.
- Undergraduate degree or its international equivalent in clinical science or health-related field from an accredited institution
- Strong experience, at least 4 years, in monitoring complex and/or global trials with a Pharmaceutical or CRO background
- Solid understanding of ICH / GCP regulations
- Knowledge of clinical/health systems as well as knowledge of cultural/professional practices in Australia
PERSONAL ATTRIBUTES AND SKILLS
- Attention to detail and ability to work simultaneously on multiple priorities.
- Self- starter with ability to adapt and be flexible to changing priorities
- Comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
- Ability to multi-task work effectively to maintain demanding timelines
- Excellent verbal and written communication
- Strong organisational and planning skills
- Ability to work independently and as a team player able to lead collaborative, efficient and effective teams
- Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel
- Willingness to travel
- Valid drivers licence and passport
Clinical Trials Assistant