CNS is a small-medium size company with a highly experienced and very motivated team.
CNS welcomes unsolicited CVs from people wishing to work with us in Clinical Operations in Australia or New Zealand or to join our network of consultants who have specific experience working in CMC, Regulatory Affairs and Medical Writing in Australia, New Zealand, USA or Europe. Please submit your CV to the following email address: firstname.lastname@example.org
CURRENT OPPORTUNITIES | Posted 25 February 2015
Due to growth, CNS is recruiting for a number of Australian locations to add to our highly motivated team of professionals. These roles are either home or office based.
Senior/Clinical Research Associate (Full or Part-time)
You will perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH GCP, local regulations and SOPs. You conduct site visits to assess protocol, regulatory compliance and manage the required documentation as well as be responsible for ensuring patient safety and data collection quality.
Qualifications required are a degree in life sciences (e.g. BSc, RN or BPharm) and at least 3-5 years prior working experience in clinical research role, managing investigator sites and conducting monitoring visits, in a pharmaceutical, biotechnology company or CRO environment. Working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
Job location: Head Office (Brisbane) or Home based (Adelaide, Sydney or Melbourne).
CNS has further opportunities for an experienced Quality Assurance professional in the role of QA Associate to join our team in Brisbane. Reporting to the Director, Quality Assurance, you will be responsible for the following tasks:
• Perform duties as Document Controller, managing the CNS Quality Documents process
• Track and compile non-compliance and corrective and preventive action plans (CAPA) reports
• Support the Quality team during the internal audit process
• Support the Quality team to conduct remote vendor qualification audits
• Support Vendor Qualification Audits at CNS
• Support GCP related Regulatory inspections as necessary
• Act as internal consultant for GCP related topics
• Assist in the preparation of reports to Management documenting audit activities, metrics, findings and resolutions; and raise significant issues of non-compliance
• Participate and/or lead process improvement initiatives related to QA auditing and related processes
• Assess and manage departmental process requirements.
Qualifications required are a degree in a biomedical field or equivalent (e.g. BSc, RN, Bpharm) and at least 2 years' experience in QA or in a related field. Strong knowledge of ICH-GCP Guidelines including international regulatory requirements and proven project management skills. Prior CRO experience is highly regarded. Available for interstate and international travel. Ability to work in a proactive and autonomous manner as well as being part of a team, a high level of attention to detail, excellent communication skills and computer competency, will ensure success in this role.
In return, CNS offers the successful candidate the opportunity to work in a highly client orientated, rapidly growing integrated service company within a responsive, internationally experienced team.
Like to apply?
Only applicants who are currently in Australia and have a legal entitlement to work in Australia, will be considered. Fluency in English is an absolute requirement.
For more details and to apply - in strictest confidence -please submit your cover letter and CV to the:
Director Human Resources: email@example.com
Applications Close 01 June 2015