Jamie Bennett Email & Phone Number

Durham, Nc, Us

United States

**Site Management and Communication**- Facilitate the seamless exchange of data, documents, and critical project information between investigative sites, site vendors, the project team, and other PSI departments.- Manage the lifecycle of clinical supplies, including order processing, receipt, inventory storage, distribution, return/recall, and reconciliation.- Oversee regulatory submissions and ethics committee notifications to ensure compliance with all necessary guidelines.- Administer site and vendor payments efficiently, as required by the project.- Coordinate and prepare for site, Trial Master File (TMF), and systems audits and inspections, including follow-up actions.- Review and coordinate site-specific Electronic Data Capture (EDC) completion, providing regular updates to the site Monitor on the status.- Support the organization of internal team meetings, including the preparation of agendas and minutes, as well as Investigator’s Meetings.- Maintain and update study-specific and corporate tracking systems to ensure accuracy and consistency.**Document Management**- Oversee the maintenance and compliance of the Trial Master File (TMF) at the country/site level, ensuring that all documents are properly archived and accessible.- Prepare, distribute, and update Investigator Site Files (ISF) and associated checklists to ensure all required documentation is complete.- Review and monitor the translation status of study documents to ensure timely availability.**Safety Management**- Ensure the proper flow of safety information between investigative sites to maintain patient safety and regulatory compliance.**CTMS Management**- Update Clinical Trial Management System (CTMS) with accurate project information.- Support Monitors by ensuring the timely completion of all subject and site event information in the CTMS and by meeting deadlines for site visits and visit reports.

Durham, North Carolina, United States

•Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.• Assist with periodic review of study files for completeness.• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

North Carolina, United States

Durham, North Carolina

Associate'S Degree, Accounting And Finance

Course work includes accounting, finance, ethics, business law, computer applications, financial planning, insurance, marketing, real.

Associate Of Science - As, Clinical Research Associate

Course work includes in-depth study of drug development, Federal regulations, and clinical research processes. Supervised fieldwork.

Clinical Reaearch Monitor Certificate, Monitoring Clinical Trials

This course covers the fundamentals of monitoring clinical trials, including the regulatory requirements for monitoring, how to conduct.

College/University Preparatory And Advanced High School/Secondary Diploma Program