Job DescriptionDo you want to make a difference? Are you ready to give your best to what may become the most exciting professional challenge in your career?
CRA/SCRA required with LOCAL EXPERIENCE in a similar role
Independent Monitoring Experience as a CRA/SCRA is a MUST
Competitive pay and opportunity for significant travel bonus
No Site Matrix
Home based/Office based options
The scope of responsibilities will include:
- Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
- Site management, general administration of clinical research studies in Australia.
- Contact for clinical investigators, vendors and support services in regard to study progress
- Monitoring trial progress and ensuring that the project timelines are met
- Facilitation of site budgets and contract negotiations
- Effective and open communication within the project team
- Delivering onsite training of investigators and staff
- Preparation and delivering of presentations at Investigator's Meetings
- Preparation for and attendance at company's audits; resolution of audit findings
- Support to global Regulatory Affairs in procurement of site regulatory documents
- Maintenance of appropriate documentation regarding clinical site management
- Participation in feasibility research
- Participation in query resolution
- Maintenance of study-specific automated tracking systems
University degree in Life Sciences, Pharmacy, MD or RN or an equivalent combination of education, training and experience
- At least 2-3 years of LOCAL experience at a similar position, with full scope of monitoring responsibilities within Phase I/II/III Clinical Trials.
- Independent monitoring experience in Australia.
- Experience in regulatory submissions, contract negotiations, site management and feasibility assessment
- Fluent English, spoken and written.
- Team oriented with excellent communication and interpersonal skills including a positive and professional attitude to tasks and projects
- Good problem solving abilities, flexibility
- Valid driver's license and ability to travel
- Demonstrated computer skills (MS Office applications)
- Full working rights in Australia
Please feel free to contact at email@example.com for more information or Call 02-9696 8000.