Anna Phillips Email & Phone Number

Remote - TN

Remote

• Global Document Review Lead ensuring compliance with sponsor and local regulatory requirements and clinical practice Good Clinical Practice (GCP) guidelines.
• Reviewed/approved initial/amended protocols for thoroughness and completeness in direct collaboration with the sponsors for central IRB submissions and to be sent to local IRB sites.
• Reviewed/approved Core/Country/Site Informed Consent Forms (ICFs) and patient-facing materials in direct collaboration with the sponsors for IRB submissions.
• Reviewed/approved Investigator Packages (IPs), including study start-up documents (i.e. 1572s, FDFs, CVs, MLs, IRB approval docs, lab docs, etc.).
• Granted regulatory greenlight to a site to begin enrolling patients into the clinical trial. Assigned to several studies at one time (sometimes 10+) with anywhere from 5-100 sites each.
• Drafted Investigator Package Plans (IPPs) that document the required quality of documents included in IPs.

Dickson, Tennessee

• Regional Document Review Lead to ensure compliance with sponsor and local regulatory requirements and clinical practice GCP guidelines.
• Reviewed/approved protocol amendments and amended Core ICFs for thoroughness and completeness in direct collaboration with the sponsors for central IRB submissions and to be sent to local IRB sites.
• Reviewed/approved Country/Site ICFs and patient-facing materials in direct collaboration with the sponsors for IRB submissions.
• Reviewed/approved IPs, including study start-up documents (i.e. 1572s, FDFs, CVs, MLs, IRB approval documents, lab documents, etc.).
• Granted regulatory green light to a site to begin enrolling patients into the clinical trial.
• Reviewed IPPs that document the required quality of documents included in IPs.

• Primary contact with investigative sites during site start-up activities to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by.
• Reviewed Core/Country/Site ICFs and patient-facing materials in direct collaboration with the sponsors.
• Resolved ICF and contractual language issues by exercising advanced judgment when interacting with study sites.
• Draft, negotiated and finalize contracts and budgets with investigative sites within parameters provided by sponsors.
• Performed central IRB/IEC submissions; prepared investigator submission packages for local IRB/IEC.
• Developed project-specific plans for study start-up of assigned studies.

• Developed relationships with Key Opinion Leaders, Site Networks, Site Management Organizations and other independent sites in key therapeutic/specialist areas that were aligned with the project profile of the Division.
• Performed rapid and accurate feasibilities (internal and external) for new, potential and existing projects in order that recruitment strategies (including site/country recommendations) could be proposed to ensure.
• Provided strategic input into Project Plans and Proposals.
• Conducted thorough site identifications while working closely with the project managers, project teams, sites and/or sponsors.

Nashville, TN

Nashville, Tennessee

Nashville, Tennessee

Nashville, TN