Senior Clinical Research Associate - RELOCATION SUPPORT OFFERED
ARE YOU AN EXPERIENCED CLINICAL RESEARCH ASSOCIATE??? ARE YOU INTERESTED IN RELOCATION TO AUSTRALIA???
Sam Whyley-Smith at CK Clinical is recruiting for multiple Senior Clinical Associate's to join a leading CRO based in Adelaide, Australia and monitor early phase clinical trials across multiple therapeutic areas for their pharmaceutical and biotechnology clients.
Reporting into the Senior Project Manager the main purpose of the role will be to perform activities associated with the evaluation, initiation, monitoring and close out of clinical trials to ensure the trial is conducted in accordance with the protocol, SOPs), ICHGCP guidelines and other applicable regulatory requirements.
Responsibilities will include to:
- Coordinate allocated projects and project activities in accordance with company guidelines and SOPs with minimal supervision.
- Coordinate the required activities of stakeholders in the clinical project management process including sponsor, site and monitors.
- Monitor all aspects of studies to ensure compliance with GCP, study protocol and regulatory requirements and prepare monitoring reports.
- Perform Study Initiation, On-study and Study Close-out activities.
- Verify subject records, review essential documents, perform investigational product accountability, meet with site personnel and ensure procedures are conducted per the protocol.
- Site management between monitoring visits, contact sites, ensure adequate enrolment and document collection as required.
- Develop and review study protocols and other study related documents.
- Prepare documents related to a clinical trial.
- Perform internal review of study documents.
- Prepare ethics submissions.
- Design and review of Case Report Forms.
- Assist in preparation of Clinical Study Reports.
- Other duties as directed by Line Management or delegate.
- Bachelor's level degree in Life Sciences, Pharmacy, Nursing or appropriate industry experience.
- Experience working as a Clinical Research Associate (CRA) and SCRA.
- Minimum 3-5 years experience in the pharmaceutical industry/Contract Research Organisation (CRO) working in a GCP environment.
- Formal CRA and ICH GCP training.
- Highly developed computer skills especially MS Office Suite.
- Ability to understand technical, scientific and medical information.
- Proven ability to work autonomously.
- Excellent time management and organisational skills.
- Proven ability to maintain strict adherence to client confidentiality issues.
- High level of written and verbal communication skills.
- Proven ability to deliver tasks on time and with a high degree of accuracy.
- Demonstrated initiative, trust and reliability and the ability to work unsupervised.
- Ability to communicate effectively, in writing and verbally, with a wide range of people.
- Proven ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate a number of tasks simultaneously.
- Willingness to work in and be supportive of a positive and dynamic team culture.
- Ability to travel interstate.
- Dependent on experience between $115,000 - $130,000 basic salary + 9.5% Superannuation.
- Relocation support offered for individual and family including VISA support.
For more information or to apply for this position, please contact Sam Whyley-Smith on 01246 580040 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47077 in all correspondence.