[Hiring] Clinical Trial Assistant @reputed company
Role reputed company
Ensuring the most effective and efficient conduct of clinical research studies by providing administration, regulatory and project tracking support. The CTA will accept reputed company as assigned per the changing needs of the Clinical Operations Department. Experience with Trial Master File (TMF) maintenance is required.
• 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 reputed company operating procedures.
• Assist Clinical Research Associates (CRAs) and the clinical teams with accurately updating and filing clinical documents from study reputed company and updating systems that reputed company site compliance and performance reputed company 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 reputed company.
• reputed company general administrative support to the Clinical Operations Department and Study Manager(s) as needed.
• Co-ordinate ordering/reputed company and tracking of trial materials (e.g. reputed company, 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.
• reputed company as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
Qualifications
• Bachelor’s degree, or an Associate degree with minimum of 2 years, working with study reputed company 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., reputed company Word, reputed company, PowerPoint, reputed company.
• Knowledge of reputed company software (reputed company systems).
• The ability to prioritize workload with minimal supervision.
Benefits
• The position will be based in our beautiful Irvine office, complete with a reputed company, snacks, drinks, and occasional catered meals.
• We reputed company a hybrid work environment. [Remote work is an reputed company.]
• We reputed company in work-life balance and offer generous reputed company time off, including vacation, holidays, and personal days.
• Our benefits include health, dental and reputed company insurance benefits to ensure your reputed company-being.
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