Clinical Study Administrator

The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities
from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

CSAs might have different internal titles based on the experience level . The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head.

To be an integral part of the study team by providing administrative and project tracking support to the Project Manager(s) and Clinical Trial Manager with emphasis on supporting inspection readiness

Assists in coordination and administration of clinical studies from the start-up to execution and close-out.

Recognize, exemplify and adhere to ICON's values which center on excellence in execution, exceeding expectations, and enhancing relationships
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Travel (approximately 10%) domestic and/or international
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, organization and maintenance of clinical study documentation (e.g. Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival
To assist in the processing of Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study
To share responsibility in the quality control audits of clinical study documentation (e.g. Study Files, CRF Files, Monitoring Files, etc.) to ensure study files are inspection ready at all times
To facilitate and coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies, and study binders) as appropriate
To assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate)
To run, review and analyse study reports for accuracy and work with the project teams to ensure updates are completed correctly
To assist in coordination of study related payments, if applicable
To contact and serve as a contact for clinical sites for basic requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.)
To assist in the tracking and distribution of safety reports
To coordinate document translation, if required
To assist and attend the Project team with meeting coordination, activities preparation, generation of meeting minutes and agendas
To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations
To assist with the coordination of various tracking reports, including but not limited to, team member tracking and training
To work in collaboration with internal and external colleagues to meet project objectives and timelines
To Keep the Project Manager / Project Director / Clinical Operations Designee informed of any issues within the Project Team which require attention
To maintain client and patient confidentiality
Other duties as assigned

Essential
• High school/Secondary school qualifications (*), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.

• Previous administrative experience preferably in the medical/ life science field.

• Proven organizational and administrative skills.

• Computer proficiency.

• Good knowledge of spoken and written English.