Responsibilities
- Organize and maintain clinical study documentation (e.g., Trial Master Study Files) including preparation for internal/external audits, final reconciliation and archival.
- Responsible for the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist Clinical Research Associates (CRAs) and the clinical teams with accurately updating and filing clinical documents from study visits and updating systems that track site compliance and performance within project timelines.
- Completes periodic review of study files for completeness and audit readiness.
- Assist Study Manager with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assist with the tracking and management of study trial data, queries, and clinical data flow.
- Provide general administrative support to the Clinical Operations Department and Study Manager(s) as needed.
- Co-ordinate ordering/dispatch and tracking of trial materials (e.g. source, diary cards, lab supplies, drug supplies) as appropriate.
- Contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.).
- Assist in the tracking and distribution of safety reports.
- Co-ordinate document translation, if required.
- Attend clinical team meetings and generate meeting minutes.
- Assist in the production of PowerPoint slides, including graphics, as needed for project, departmental, sponsor and/or business development presentations.
- Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
Requirements
- Bachelor’s degree, or an Associate degree with minimum of 2 years, working with study related regulatory files.
- Experience working with and maintaining, an electronic Trial Master File.
- Must be familiar with ICH/GCP guidelines and appropriate regulatory regulations.
- Strong organizational skills with the ability to manage multiple tasks with meticulous attention to detail.
- Excellent written and verbal communication skills.
- Computer literacy: e.g., Microsoft Word, Excel, PowerPoint, Outlook.
- Knowledge of clinical trials software (eDC systems).
- The ability to prioritize workload with minimal supervision.
Benefits
- health, dental and vision insurance benefits to ensure your well-being.
- generous paid time off, including vacation, holidays, and personal days.
Additional Information
- Some travel may be required – up to 10%
- The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals.
