• Works collaboratively with Clinical Monitoring staff on site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines• Creates and assists cross-functionally with maintenance of project files, including project correspondence• Responsible for completing eTMF file audits• Prepares and maintains site manuals, reference tools and other documents • Maintains, updates, and inputs clinical tracking information into databases• Tracks and updates incoming and outgoing clinical and regulatory documents for investigator sites, studies, project team, or client• Manages shared mailbox, processes site requests and routes correspondence appropriately• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes as well as action items• Anticipates, identifies and resolves potential issues - Implements corrective actions, seeking appropriate guidance as needed to resolve more complex problems• Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training• Provides training or mentorship to inexperienced Clinical Operations Specialists

• Supported the project team to ensure the services and expectations of a clinical trial are completed in accordance with the executed contract and the customer’s expectations• Tracked and analyzed project details and maintained internal systems for assigned project• Ensured adherence to Good Clinical Practices, regulations, and project procedures• Utilized designated clinical trial management systems to track, process, analyze and present clinical trial information, (e.g., regulatory documents, enrollment, SAE/ AEs, protocol deviations, supplies, IRB re-approvals, data queries)• Updated upper management of site and study status• Collected, tracked, and authorized payment of site invoices and grants• Contacted specific site staff for critical information• Scheduled and attended internal and external team meetings as well as team trainings and off-site sponsor related meetings• Led sections of the internal and external team meetings• Recorded team actions items and follows up to ensure completion• Distributed and collected important study information for specific study sites• Organized meetings with other project specialists to ensure tasks are being completed• Managed, tracked, reviewed quality, submits, and organizes documents into the Trial Master File• Regularly attended internal and external trainings and SOPs related to Syneos & specific projects• Created study newsletters and study advertisements for site staff to utilize

• Supported the project team to ensure the services and expectations of a clinical trial are completed in accordance with the executed contract and the customer’s expectations• Tracked and analyzed project details and maintains internal systems for assigned project• Ensured adherence to Good Clinical Practices, regulations, and project procedures• Utilized designated clinical trial management systems to track, process, analyze and present clinical trial information, (e.g., regulatory documents, enrollment, SAE/ AEs, protocol deviations, supplies, IRB re-approvals, data queries)• Updated upper management of site and study status• Collected, tracked, and authorized payment of site invoices and grants• Contacted specific site staff for critical information• Scheduled and attended internal and external team meetings as well as team trainings and off-site sponsor related meetings• Led sections of the internal and external team meetings• Recorded team actions items and follows up to ensure completion• Distributed and collected important study information for specific study sites• Managed, tracked, reviewed quality, and submitted documents • Regularly attended internal and external trainings and SOPs related to INC & specific projects

• Supported the project team to ensure the services and expectations of a clinical trial are completed in accordance with the executed contract and the customer’s expectations• Tracked and analyzed project details and maintains internal systems for assigned project• Ensured adherence to Good Clinical Practices, regulations, and project procedures• Utilized designated clinical trial management systems to track, process, analyze and present clinical trial information, (e.g., regulatory documents, enrollment, SAE/ AEs, protocol deviations, supplies, IRB re-approvals, data queries)• Updated upper management of site and study status• Collected, tracked, and authorized payment of site invoices and grants• Contacted specific site staff for critical information• Scheduled and attended internal and external team meetings as well as team trainings and off-site sponsor related meetings• Led sections of the internal and external team meetings• Recorded team actions items and follows up to ensure completion• Distributed and collected important study information for specific study sites• Managed, tracked, reviewed quality, and submitted documents • Regularly attended internal and external trainings and SOPs related to INC & specific projects

• Scanned and published electronic case report forms and regulatory documents• Archived physical and digital regulatory documents in accordance with SOPs• Reviewed regulatory documentation required for approval to initiate clinical trials• Conducted quality control review of regulatory documents, e.g. Clinical Study Reports• Scanned, sorted, filed, and indexed documents for the eTMF• Participated in regular training workshops and online courses to stay current on SOPs and regulations related to eTMF filing

• Provided administrative and technical support to Regulatory Affairs staff, including word processing, copying, preparing spreadsheets, preparing mailings• Set-up and maintained project related files in archives; both paper and electronic archiving• Shipped supplies and documents• Copied and assisted in assembling regulatory submissions• Scanned documents for electronic distribution and/or for regulatory submissions• Retrieved documents from the archive