Jill Warren Email & Phone Number

Raleigh, NC, US

Raleigh

• Serve as project associate for multiple US and global device studies and work with all cross functional departments.
• Establish and maintain relationships with external vendors, study sites and team members to ensure professional, timely, and ongoing communication and documentation for each project.
• Track, review and prepare study-specific information utilizing databases, spreadsheets, and other tools and systems (IVRS, EDC, etc) for reporting status updates to the team.
• Prepare and negotiate CDAs, Master Services Agreements and Clinical Trial Agreements with sites and vendors. Liaise with Legal to ensure documents are routed and prioritized efficiently.
• Work with Compliance to generate HCP Consulting Agreements. Use the Heuron tiering tool, to determine Fair Market Value (FMV).
• Review, approve and track all invoices from vendors and sites. Report monthly accruals to Program Manager.

Raleigh-Durham, North Carolina Area

• Coordinated close-out activities with sites and CRAs for 2 global multi-center influenza trials to meet database freeze and archiving timelines.
• Assisted in development of Study Administrative Table and modular appendices for Clinical Study Reports for timely regional and global Regulatory submissions.
• Conducted study start-up activities for a Respiratory device study including development / set-up of electronic document exchange system, site selection, review of informed consents and IRB submissions.
• Provided oversight of TCS in India responsible for the collection and review of regulatory documents from US sites for 4 multi-center trials.
• Audited and reconstructed paper TMF of out-sourced Oncology to provide an organized file structure for the CRO in the event of an audit..
• Trained GSK staff on systems and processes to provide seamless transition of responsibilities.

RTP

• Developed study specific processes & procedures for operationalizing studies and oversee standardization, dissemination of best practices that streamlined GSK’s document exchange between sites and reduced turn-around.
• Influenced internal & external partners through best practice applications that ensured current and accurate information was communicated
• Built collaborative relationships with Investigator site staff, CRAs and study teams.
• Primary point of contact for central IRB in study set-up, submissions, approval of ICF templates, translations and advertising materials.
• Supported site staff with access to relevant study systems and ensured sites were compliant with project specific training requirements, regulatory documents, data queries and study timelines.
• Assisted contracts group to manage and stay within the site / study budget and contract negotiations.