Clinical Project Associate
Clinical Project Associate III Supported clinical project team by maintaining activities of several clinical trial studies to ensure required regulatory documents were accurate, current and all other related clinical documents filed appropriately in the file management system. Coordinated with SSU group to ensure regulatory documents were prepared and completed in a timely manner before SIV, to ensure proper timing of study start up. Ensured site creation into database management to certify that all confidential information was handled as per company SOPs. Prepared study site binders, distributed updated clinical trial materials and tracked information in tracking log to properly maintained operational regulatory requirements and site payments of each clinical trial study from initiation through study closeout. Updated key dates and study team roster in study database management. Communicated tracking updates of performed duties regularly to cross-functional team to ensure quick responses to inquires or concerns. Prepared enrollment reports and proactively monitored patient enrollment of each site to accurately maintain study documentations, IRB submissions/approvals, site payments and good record keeping of staff changes to support on-site audits. (file management) Audited study files quarterly for accuracy and completeness to ensure 100% regulatory compliance. Created payment schedule to ensure timely quarterly site payments, tracked, reconcile and compensated within the required time frame.
