● Provided support for efficient project meetings, both internal and external, including scheduling and leading (as necessary), preparation and distribution of meeting minutes, maintenance of action item and decision log ● Supported start-up activities, including site selection, collection of regulatory documents and site activation. Managed and tracked study team/contact list and system access requests. Maintained the study training matrix and worked on ISF binders ● Maintained and… Show more ● Provided support for efficient project meetings, both internal and external, including scheduling and leading (as necessary), preparation and distribution of meeting minutes, maintenance of action item and decision log ● Supported start-up activities, including site selection, collection of regulatory documents and site activation. Managed and tracked study team/contact list and system access requests. Maintained the study training matrix and worked on ISF binders ● Maintained and evaluated study progress by using BioClinica EDC and BioClinica CTMS ● Updated and maintained BioClinica CTMS and BioClinica EDC within project timelines ● Collected, reviewed, maintained, and ensured Veeva eTMF is accurate, complete and audit ready in accordance with Good Clinical Practice ● Reviewed, uploaded, and ensured correct metadata for up to 300 documents within a week in WingSpan eTMF ● Prepared, handled, and distributed Clinical Trial Supplies and maintenance of tracking information for up to 40 sites at a time Show less

• Supported project team as needed• Assisted with start-up activities to include site regulatory document collection• Updated and maintained clinical systems within project timelines• Prepared, handled, distributed, filed, and archived clinical documentation and reports• Collected, reviewed, and maintained TMF system in accordance with Good Clinical Practice • Reviewed study files periodically for accuracy and completeness• Prepared, handled, and distributed Clinical… Show more • Supported project team as needed• Assisted with start-up activities to include site regulatory document collection• Updated and maintained clinical systems within project timelines• Prepared, handled, distributed, filed, and archived clinical documentation and reports• Collected, reviewed, and maintained TMF system in accordance with Good Clinical Practice • Reviewed study files periodically for accuracy and completeness• Prepared, handled, and distributed Clinical Trial Supplies and maintenance of tracking information• Tracked and managed Case Report Forms (CRFs), queries and clinical data flow.• Performed administrative tasks to support team members with clinical trial execution as needed. May act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation• Assisted sites with preparation for planned and unannounced audits with some guidance. Organized project meetings and taking of minutes. Maintained appropriate professional relationships utilizing an assertive, business-like manner which fosters study compliance Show less

• Review and approve timesheets and expenses for Contract CRA team. When required, request approval for time billed outside of project team budget. Once time has been approved, enter into time tracking system• Escalate late SVRs, follow up letters or other pending deliverables to appropriate project team, line manager, and/or agency for corrective action• Send regular communications to sites requesting feedback on contractor performance• Maintain Contract CRA ELVIS filing. This… Show more • Review and approve timesheets and expenses for Contract CRA team. When required, request approval for time billed outside of project team budget. Once time has been approved, enter into time tracking system• Escalate late SVRs, follow up letters or other pending deliverables to appropriate project team, line manager, and/or agency for corrective action• Send regular communications to sites requesting feedback on contractor performance• Maintain Contract CRA ELVIS filing. This includes tracking tools, on-boarding/off-boarding documentation, feedback files on each CRA, training documentation, and contacts for all CCRAs• Communicate and execute updates in policy and training to contract staff• Support line manager with onboarding and offboarding contract CRAs (maintains offboarding/onboarding trackers and contact records, verifies completion of trainings, ensures equipment is returned and proper accesses are removed post departure)• Support resourcing management with CRA requests and assignments by adhering to an internal resourcing process. Ensure that any updates made to assignments are properly reflected in both QRPM and tracking• Maintain a weekly report used by senior management that consolidates several data points for CRAs including site assignments, scheduled workload, and future projections for potential financial opportunities•Communicates with project teams to gain accurate information on their resourcing request and project details, as well as relaying any necessary actions needed for proper use of the system• Manages tracking of state statuses related to COVID-19 restrictions to recover revenue-generating visits across the US & Canada Show less

•Greeted guests and provide pertinent information related to their stay (i.e., Amenities of the hotel, local eats, directions to popular tourist sites)•Adhered to the corporate standards of customer service when providing updates and general communications verbally or via email.•Registered and logged keys for the guests.•Reviewed financial data in proprietary system and confirmed accuracy of given information•Reported and escalated deficiencies with guest rooms to housekeeping… Show more •Greeted guests and provide pertinent information related to their stay (i.e., Amenities of the hotel, local eats, directions to popular tourist sites)•Adhered to the corporate standards of customer service when providing updates and general communications verbally or via email.•Registered and logged keys for the guests.•Reviewed financial data in proprietary system and confirmed accuracy of given information•Reported and escalated deficiencies with guest rooms to housekeeping services and maintenance personnel to ensure completion in a timely manner Show less