We’re searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service global projects in Australia. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.
Location: Macquarie Park, NSW
- Training, mentoring and supervising study level responsibilities for Jr. CRAs
- Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
- Delivering training of investigators, site staff and project teams
- Work with complex studies
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Be involved in site identification process
- Contact for clinical investigators, vendors and support services in regard to study progress
- Participate in feasibility research
- Preparation and delivering of presentations at Investigator’s Meetings
- Preparation for and attendance at company’s audits; resolution of audit findings
- Support to Regulatory Affairs in procurement of site regulatory documents
- Maintenance of study-specific automated tracking systems