Senior/Clinical Research Associate - NSW, VIC, QLD, SA
Be the face of a Global CRO and part of a flexible and progressive clinical team
Summary about this job
Clinical/Medical Research
Company: On Q Recruitment Pty Ltd
Location: Sydney
Work type: Full Time
Salary: n\a
Phone: +61-2-2077-1039
Fax: +61-2-2528-5026
E-mail: n\a
Site: n\a
Detail information about job Senior/Clinical Research Associate - NSW, VIC, QLD, SA. Terms and conditions vacancy
•Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
•Function as a mentor and role model for other CRA team members
•Provide study specific training for CRAs acting as a lead CRA on individual projects
•Establish site recruitment plan in collaboration with site during qualification visit; follow-up and update at initiation visit and monitoring visit
•Attend external client meetings and presentations including investigator meetings and professional conferences
•Manage clinical monitoring activities, including:
- Arranging on-site visits and logistics
- Establishment of a site recruitment plan in collaboration with site staff during QV
-Monitoring completeness and quality of Regulatory Documentation - Performing site documentation verification
- Data collection and drug accountability in accordance with ICH GCP guideline
- Monitoring patient safety on-site and addressing any violations in a timely manner
Minimum requirements:
At least 1 yr of monitoring experience in Australia is required.
Substantial monitoring experience in clinical research/Clinical Research Organizations
Educated to degree level (biological science, pharmacy or other health related discipline)
Strong working knowledge of EDC systems and IVRS
Solid understanding of therapeutic indications and study protocol
Ability to lead a "virtual" team
Competent in written and oral English and local
For a confidential discussion, please call Candice Howells on +612 9431 2565. To apply, please send your Cover Letter and Resume, Word Format recommended (no tables or text boxes), quoting the reference number. Visit onqrecruitment.com.au to review all our current vacancies.