To provide general administrative support to the Clinical Operations Department and assistance to the Project Manager(s) and Project Director(s).
• To assist the Clinical Operations teams in completing 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, and appropriate regulations.
• To be familiar with the roles of the Clinical Research Associates (CRA)

• To assist project teams with study-specific documentation and guidelines.
• 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, and quality control as appropriate for each study.
• To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
• To coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
• 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 attend project team meetings and generate meeting minutes.
• To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation, and generating meeting minutes.
• Other duties as assigned 

JOB FUNCTIONS/RESPONSIBILITIES: