PURPOSE OF THE JOB:
?To assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support.
JOB FUNCTIONS/RESPONSIBILITIES:
?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
QUALIFICATIONS/EXPERIENCE REQUIRED:
?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%)