CTA

·         *To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).

·         To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.

·         To support the Clinical Operations teams with ongoing conduct of studies.

·         *To be familiar with ICH GCP, appropriate regulations, relevant ICON SOP’s and ICON internal tracking systems.

·         To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.

·         To assist project teams with study specific documentation and guidelines as appropriate.

·         *To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.

·         *To process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.

·         *To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).

·         *To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.

·         *To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.

·         *To copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.

·         To assist in co-ordination of Investigator payments, if applicable.

·         To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).

·         *To assist in the tracking and distribution of safety reports.

·         To co-ordinate document translation, if required.

·         To attend project team meetings and generate meeting minutes.

·         To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.

·         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 team member tracking.

Other duties as assigned

QUALIFICATIONS/EXPERIENCE REQUIRED:

·         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. (US only)

·         Either relevant work experience or High School Diploma (or equivalent).

·         Research or health care related academic or work experience preferable.

·         Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.

·         Good written and verbal communication skills.

·         Good written and spoken English.

·         Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.

·         Willingness to travel for job related activities if required (expected travel for this position is < 10%).