Must have-Full working rights in Australia.
CRA/SCRA is required by a global CRO for a home based/office based positions available nationwide with 50% travel.
- This is a permanent, full time position multiple openings. The role involves monitoring Clinical Trials in various therapy areas, mainly in Oncology Phase I- IV clinical study sites in Australia.
- To perform the activities associated with the site-level feasibility, evaluation, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trial sites in the geographic area assigned.
- Responsible for Site management, set up, routine monitoring and close out visits
- Writing monitoring reports
- Liaising with investigators and other members of a multi-disciplinary team
- Variety of therapy areas, which may include oncology, cardiovascular, CNS, respiratory and/or infectious diseases
- Delivering onsite training of investigators and staff.
- Monitoring trial progress and ensuring that the project timelines are met.
- To act as an extension of, and whenever appropriate a surrogate in the field for, the TA study teams and other HQ-based Development Operations functions
- To align execution activities with agreed-upon project priorities, timelines and quality/productivity specification, in compliance with GCP and local laws and regulations governing the conduct of clinical research.
- Monitoring Plan
- Clinical site visit reports
- List of qualified sites following feasibility conduct (shared deliverable)
- Site specific patient recruitment and retention plans (shared deliverable)
- Collection of high-quality clinical trial data (CRFs)
- Query resolution
- Corrective and preventative action responses to monitoring-related observations on audits and inspections
- Territory Development strategic plan (shared deliverable)
- Response to requests for site level study and/or territory information
- Site Monitor : 50%-60%
- University degree in Life Sciences, Pharmacy, MD or RN or an equivalent combination of education, training and experience.
- At least 2-3 years of 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.
- Preferably with Experience in Oncology, Infectious Disease or Neurology.
- Full working rights in Australia.
- Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
- A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
Please feel free to contact at faiza.khan @ nesgt. com for more information/Call 02-9696 8008.