Reports to: Group Leader Clinical
An exciting opportunity has arisen for a CRA to join a growing global CRO in the Australia division in 2021. The CRA will have access to excellent management and leadership to guide them through a variety of different studies across a range of therapeutic areas. The sites will be across Australia and this unique opening will provide every opportunity to a high performing CRA to take their career onto the next level.
Main Role:
- Conducts and documents Pre-Study Visits (PSVs), Study Initiation Visits (SIVs)/Qualification Visits (QVs), Monitoring Visits (MV) and Closedown Visits (CV) as per Acceler8 SOPs
- To monitor and report on Investigator’s adherence to approved protocol/amendments and on study conduct at each study site
- To ensure that the Investigator maintains all essential documents and that study related documents, including but not limited to source documents and case report forms, are complete and accurate
- To assist with feasibility studies
- Manage timely compilation and submission of Ethics Applications and assist in Regulatory applications where required
- Conduct telephone calls to investigator sites to evaluate potential patient eligibility and enrolment, and to follow-up on any outstanding issues
- Assist with investigator meetings through the preparation, assembly and shipment of training materials
- Co-ordinate the collection of essential documentation in accordance with ICH/GCP
- Identify, document and report SAEs according to ICH/GCP guidelines and local regulatory requirements, within required timelines and follow-up as required
- Conduct final IMP reconciliation, and arrange return of unused IMPs to the sponsor
- Be responsible for monitoring and maintaining IMP accountability at investigator sites
- Prepare site visit reports and status reports, document site actions in follow up letters/e-mail
- Take telephone calls from team members, investigators and sponsor. Document and follow-up these calls
- Assist Project Manager/CRA Manager with establishing and implementing the query resolution process
- Gain an in-depth understanding of the study protocol, CRF and related procedures
- Develop good working relationships with investigator site personnel and provide support, training and motivation
- TMF filing and review, as required
- Assist with general project administration
- Be responsible for filing of documentation regarding designated sites
- Adapt protocols/informed consent forms to country specific requirements
- Develop/implement project specific monitoring tools and tracking forms under the direction of the Project Manager/CRA Manager
Educational requirements:
- Degree in Life Sciences
- At least 2 years’ experience as a CRA, preferably within a CRO environment
Position requirements:
- Full driving licence with the ability to travel up to 3 days/week
- Would consider Full Time or Part Time
- Would consider Home Working
Key skills required:
- Fluent written and oral English language including familiarity with medical terminology
- Good oral and written comprehension, professional communication
- Able to work with minimum supervision
- Ability to order and prioritise tasks
- Numeracy
- Good attention to detail
- Excellent time management skills
- Professional/Technical interest
- Computer Literacy
- Good Initiative/Self-starter
- Enthusiasm/motivation
BENEFITS
Acceler8 Clinical Research has offices in the UK, Australia and Singapore. We operate throughout Europe, North America, South America, India, China, Africa and Australasia. Our expanding company provides clinical trial services and support to the pharmaceutical and medical device sector.
Acceler8 Clinical Research offers the opportunity to work on clinical trials of real scientific merit, genuinely working in partnership with our Clients to help deliver new treatments for unmet needs. Working within a highly motivated team, you can make an impact and see your talents rewarded.
As a progressive organisation embracing the work/life balance, we offer fantastic opportunities for personal development and advancement as well as competitive salaries, company pension scheme, private healthcare, share options, and life insurance.
PRIVACY NOTICE
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Any offer of employment will be subject to the successful candidate holding the right to work in the UK.
WE ARE SORRY BUT WE DO NOT ACCEPT APPLICATIONS FROM RECRUITMENT COMPANIES
All interested applicants should email their CV and covering letter to admin@acceler8clinicalresearch.com