Set up, organize and maintain accurate clinical study documentation (e.g. Trial Master Files etc.) and ensure compliance with regulatory requirements, including preparation for internal/external audits, final reconciliation and archival.
Ensure that documents are up-to-date, complete, and readily accessible to the clinical research team, including quality control audits of clinical study documentation
Assist Clinical Operation teams with trial progress tracking by updating the Clinical Trial Management Systems, assist in the tracking and distribution of safety reports
Provide general administrative support to the Clinical Operations team with ongoing conduct of studies and completion of all required tasks to meet departmental and project goals, including co-ordination of Investigator payments, if applicable.
Ensure successful completion of operational activities for clinical research studies within established timelines and quality standards.
Collaborate with cross-functional teams to ensure successful implementation of study plans
Assist the Clinical Operations teams
Other duties as assigned
Requirements:
Bachelor's degree in medical, para-medical or scientific fields or equivalent experience
Clinical research or a related field is preferable
Exceptional attention to detail and organizational skills
Ability to manage multiple tasks and prioritization
