...collaboration and performance.
What you will be doing:
To possess a knowledge of ICH GCP, appropriate regulations, relevant ICON SOPs, ICON internal tracking systems, and Client SOPs / Client systems (when applicable)
To assist the project teams with the set-up,...
Trabajo remoto
...specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with...
Trabajo remoto
...the contract and client expectations and regulations. Utilizes PRA SOPs, processes, and systems to complete assigned accountabilities.... ..., study/project plans, study/project reports, timelines, project SOP listing) to clients and within PRA.
• Assumes primary role in...
Trabajo remoto
...patient safety, and regulatory / compliance activities with clients and project team.
Ensures that Standard Operating Procedures (SOPs), policies and guidelines are adhered to at the project level
Ensures assignment of project specific training to project team...
Trabajo remoto
...approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
Embrace and contribute to ICON’s culture...
Trabajo remoto
...update on-site paper files, as needed.
What you will be doing:
Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, etc.
Review, administratively finalize (headers/footers/file name consistency) watermark...
Trabajo remoto
...attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
- Good English language and...
Trabajo remoto