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.• Reviewed Study Start-up Plans to ensure compliance with regulatory requirements and departmental processes.• Mentored lower level staff on ICFs and IPs.• Provided project-specific regulatory training to global study teams for each project.• Setup and maintained the study database and paper/electronic regulatory files throughout the duration of the studies.• Provided input for Corrective and Preventative Actions (CAPAs) related to Document Review activities including ICF Review, Patient-Facing Material Review and IP Review.

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.• Mentored lower level staff on ICFs and IPs. • Provided project-specific regulatory training to regional study teams for each project.• Setup and maintained the study database and paper/electronic regulatory files throughout the duration of the studies.• Provided input for Corrective and Preventative Actions (CAPAs) related to Document Review activities including ICF Review, Patient-Facing Material Review and Investigator Package Review.

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 local regulations, EU Clinical Trial Directive, ICH/GCP, FDA regulations (for IND studies) and the study sponsor.• 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.• Setup and maintained study database and regulatory files throughout the duration of the clinical trial.• Liaised with the sponsors and internal regulatory teams regarding document submission requirements.• Liaised with operational project team regarding project issues.• Assessed impact of changes in study personnel and document amendments on regulatory documents (including ICF) and process/review/approve new documents according to ICH/GCP guidelines.• Provided milestone information for weekly analysis; monitored performance of study team with regard to project timelines.• Assisted with preparation of materials for formal client/industry presentations and for internal training assignments.• Mentored other GSS team members.

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 project delivery within specified timelines.• 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