Audrey Wright Email & Phone Number

Philadelphia, PA, US

Durham, North Carolina, US

* Build, maintain & manage strong Client and vendor relationships and understand client needs to help develop best solutions in meeting key vendor deliverables for their project* Work closely with outsourcing team on RFP development and execution, utilizing Fortrea qualified vendors for client’s specific trial needs* Review vendor proposals and contracts.

• Identifying, evaluating and qualifying of investigators; coordinate feasibility assessments; collect CDAs from sites and upload to client TMF portal.
• Conduct co-monitoring oversight visits (Interim) to ensure CRAs are in compliance with FDA regulations, GCP/ICH guidelines for various small to medium life science clients. Train and mentor junior CRAs.
• Set up and maintain study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory, or CRO
• Review and approve monitoring visit reports of CRAs; provide support, training, and vendor metric reports to CRAs.

Verona, Italy, IT

• Negotiated vendor and site agreements and budgets; managed the internal payment processes of vendors; provided invoice approvals through Navision invoicing system
• Facilitated execution of vendor contracts (Lab, IP distribution, IVRS, Specialty Lab, Data Mgmt), ensuring proposals line up with Project CRO/Sponsor agreement on scope of work; ensure timely signoff of contracts with.
• Tracked project metrics and financials in MS Project, includes updating project financial projections and reconciling with actuals.
• Managed all aspects relating to vendors, including study budget, invoicing, project plan and vendor deliverables (User Acceptance Training, Data Specification Document)
• Served as liason for all vendors; communicating effectively to study teams keeping them apprised of deliverable (contract and budget approval) and timeline status relating to study start date
• Facilitated weekly meetings with vendors, presentation of vendor slides at investigator meetings

Verona, Italy, IT

• Conducted all monitoring visits pre-study, initiation, interim and close out to Cromsource/Sponsor SOPs; performed 100% source document verification and electronic data capture at assigned sites
• Managed assigned sites for Oncology Ph II and Respiratory Ph II by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements
• Liaised with contractual vendors, Investigators, Study Coordinators, Cromsource clinical team and Sponsor team to ensure protocol is understood and followed by all parties so clinical data can be gathered without many.
• Completed timely monitoring trip reports and follow up letters to report on site’s progress, protocol deviations, regulatory document review, IP accountability, and follow up on outstanding action items from routine.
• Presented during department meetings, Investigator meetings and/or CRA calls; train and mentor Junior CRAs
• Reviewed and managed data in EDC on site and remotely; resolves issues on a continuous basis to achieve timely database lock targets

See above description in Diversified Research on 07/19Performed same duties.

Cambridge, Cambridgeshire, GB

• Served and delivered the operational aspects of clinical studies from protocol feasibility, study start-up through database release
• Provided day to day leadership to a team of 5 site managers, communicating study deliverables to be achieved
• CRO management oversight of vendors of RAVE, IVRS, ePRO, Qlab, to include setting expectations, managing timelines of their deliverables, and issue management; review site payment status via vendor portal
• Oversaw management of the trial by escalating site issues to global management as necessary
• Reviewed and finalize trip reports of CRO CRAs; ensure site and monitoring quality,regulatory and GCP compliance; provided oversight management to a team of 8 CRAs
• Provided team support for adjudication alerts, data management deliverables, preparation of meeting materials. Trained CRAs, site staff on adjudication process.

Travel to sites participating in clinical trial, ensure proper FDA & ICH/GCP guidelines being followed, follow up with detailed report outlining site's action items from site visit. Conduct Pre Study Selection Visits, Study Initiation Visits, Interim Monitoring Visits and Close out Visits in Oncology Ph II and CNS Ph III for this large CRO. Give slide.

Raleigh, North Carolina, US

Travel to sites particpating in clinical trial, ensure proper FDA & ICH/GCP guidelines being followed, follow up with detailed report outlining site's action items from site visit.

Brentford, Middlesex, GB

Coordinated and negotiated clinical trial site contract and budgets between GSK and study centers in US Vaccines groupManaged the process and workflow of contracts and ensure proper routing of documents (ICFs) for execution by corporate officersCommunicate comments regarding contract language and status of agreements to internal clients, business partners.

• Managed upto 16 sites in the US and Canada
• Performed Pre-study, Initiation, Interim, Close-Out, and Accompanied Site Monitoring visits as needed in compliance with FDA regulations, GCP/ICH guidelines and Ockham SOPs for various Phase I and II CNS, Oncology.
• Solid ability to explain technical details of protocol, protocol amendments, and changes in ICF to investigator/study coordinator to keep them informed how these changes may affect the subjects and potential subjects.
• Primary contact and liaison for all study sites which included managing/answering questions on protocol procedures and patient eligibility issues.
• Collaborated with CNS study team to develop creative advertising strategies for sites to aid in recruitment of subjects.

New York, New York, US

Developed relationships with key thought leaders, speakers and healthcare advocates to get products added to formulary for patients use and benefit. Gained exclusive formulary status in local hospitals of all products represented. Managed target industry segments, prepared forecasts, develop growth strategies, market trends, customer needs with competitive.