We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.
Who are we?
- A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence
- 20+ years of experience, ~500 people managing 39+ geographical locations throughout the Asia-Pacific region, USA, and Europe
- Full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trial
- We combine scientific leadership and global operational excellence, with strong experience in renal medicine, oncology, cardiovascular and chronic diseases across various phases to improve the health of millions worldwide.
Why work with us?
- We are a global team making a difference in the world – our clinical trials improve the health of millions worldwide
- Competitive salary and benefits
- Flexible and agile working arrangements – onsite, hybrid or WFH (dependent on location)
- Strong and diverse Learning & Development opportunities including exposure to all aspects of clinical trials with an unparalleled network of Scientific Leaders to learn from
- A focus on employee wellbeing including global employee engagement surveys, steps challenges, reward and recognition programs, team building activities and other fun events!
About the role:
The Senior / Clinical Research Associate (SCRA) is a member of the Clinical Operations group in George Clinical. The Clinical Operations group is responsible for site management, monitoring tasks and support of clinical trials. The group allocates resources to projects as appropriate to assist with the implementation of project plans and to ensure compliance with regulatory requirements and Standard Operating Procedures.
Key Accountabilities:
- Coordinate the identification, feasibility assessment and selection of investigators and sites to undertake the study
- Prepare, plan, organise and conduct pre-study (site selection) visits and report on these visits to assist in site selection
- Prepare and submit of regulatory and Ethics Committee packages and updates as appropriate in the local setting
- Negotiate site budgets, co-ordinate for site contract execution & site payments, and track site payments
- Prepare for, plan, organise and conduct site initiation visits
- Develop and maintain appropriate monitoring tools and project specific documents
- Motivate and train investigators and ensure that the study site personnel have a good understanding of the protocol, the investigational product and the requirements of the study and that they can fulfil their obligations to conduct the study accurately and to deadlines
- Mentor, coach, and train junior staff members as directed by line management
- Monitor study at allocated sites utilising both on-site and off-site activities including:
- Verification of quality, accuracy, completion, and timeliness of data
- Complete and efficient resolution of data queries, audits and issues
- Adherence to the study protocol, monitoring plan and other relevant project specific requirements
- Adherence to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of patient safety, and adverse/serious adverse events
- Collect, review (for quality and compliance) & approve essential documents from study sites and code documents for filing
- Reconcile contents of in-house files and site files for responsible sites
- Complete all monitoring activities and progress reports, accurately and within the predetermined timeframe
- Coordinate distribution, tracking, handling and destruction of Investigational Product and other study supplies per site
- Maintain study information using the clinical trial management system and any other tracking and reporting tools for the project
- Perform project site close-out visit and other site closure related activities
- Any other responsibilities assigned by line manager
What are our expectations of candidates?
- Tertiary qualifications in a related science or health care discipline
- At least five years’ experience in clinical trial monitoring within a CRO or pharmaceutical environment
- Understanding of medical terminology and physiology
- Excellent interpersonal skills, presentation skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders
- Excellent organisational skills – ability to organise, take initiative and follow up independently
- Technological proficiency including Microsoft Office packages, electronic data capture and project management systems
- Ability and willingness to travel (up to 50%)
- Driving licence
- Ability to see the big picture, yet still focus on detail and quality of work
- Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments.
We are searching for individuals who are excited by the idea of regional and global projects and teams, don’t want to get lost in a large CRO and are ready to have their ideas heard!
You will be willing to extend yourself and take on new challenges while living our values of Mutuality, Integrity, Can-do approach, Empowerment and Excellence.
How do I apply and what if I’m interested in a role in future or want to refer someone?
Apply via LinkedIn or send your CV, referral or confidential query to careers@georgeclinical.com and our friendly HR team across the world will reach out as appropriate soon. Please provide your full contact details, the location you are applying for, whether you are interested in a current or future opportunity and we’ll be in touch. We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.
How do I learn more about the roles and George Clinical?
Follow us on Linkedin to see our regular updates and how we celebrate our people and success across our business and projects! You can also visit us at www.georgeclinical.com.
We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.
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