CRA Melbourne
Responsible for conducting the activities of assigned clinical trials including monitoring and data management.
Summary about this job
Clinical/Medical Research
Company: On Q Recruitment Pty Ltd
Location: Melbourne
Work type: Full Time
Salary: n\a
Phone: +61-7-1376-4513
Fax: +61-7-9271-5433
E-mail: n\a
Site: n\a
Detail information about job CRA Melbourne. Terms and conditions vacancy
Home based CRA in Melbourne with great benefits
·CRA 24 months monitoring experience monitoring
·Oncology trials
·Home based in Melbourne - part time options available
An amazing opportunity to be a CRA - home based in Melbourne working with a reputable organization!
Fantastic working hours - 35hr week
Therapeutic/study focused training provided
12 Additional annual leave days awarded
Home based in Melbourne
Primary purpose of position
Responsible for conducting the activities of assigned clinical trials including monitoring and data management. The activities/requirements are determined by the size, type and protocol.
Key Accountabilities
• Ensure trial activities are conducted in compliance with study protocol, ICH GCP, SOP’s and other regulatory requirements.
• Manage the progress of assigned trials by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution with site staff. Manage all adverse events (AE’s and SAE’s).
• Administer protocol to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations, enquiries and issues.
• Enter and maintain data for specific clinical trial/s in the Trial Management Database. Ensure that trial data is of very high quality, check for adherence to protocols, consistency, accuracy and completeness.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Perform site initiation, monitoring and close-out visits in accordance with monitoring plan, contracted scope of work and good clinical practice.
• Manage trial medication supply in liaison with hospital pharmacies and suppliers. Manage pathology collection and shipping as required.
Competencies Required
• Tertiary qualifications in clinical or life sciences, health, nursing and/or research.
• At least two years’ experience in coordination of clinical trials including, analysis of potential patient recruitment, preparation of trial related documentation (e.g. Case Report Forms, investigator brochures, consent documents) within an academic, CRO or pharmaceutical research environment preferred.
• Working knowledge of clinical trials methodology, including Good Clinical Practice and the role of regulatory bodies.
• Highly accurate report writing skills
• Demonstrable high level communication, interpersonal and organisational skills.
• Ability to priortise, meet strict deadlines and manage multiple simultaneous tasks as a member of a multi-disciplinary team
• Demonstrate initiative
• Able to travel to meet the requirements of assigned trials.
Additional Requirements
• Provide evidence of entitlement to work in Australia
Please send your CV to Candice Howells on or call 0294312565