Alexis Lee Email & Phone Number

Creedmoor, NC, US

• Collaborate with executive leadership, change management experts, and other stakeholders to develop visual communication strategies and presentation tactics to inspire and inform internal audiences. Lead end-to-end.
• Developed and managed visual communication strategy for several study startup systems and a vendor management process optimization effort, creating deliverables to support organizational readiness at each stage of.
• Led a campaign focused on the awareness and prevention of Changes in Scope (CIS). Designed the campaign brand and distributed monthly newsletters company wide. Created promotional testimonial videos to explain the.
• Assisted with the Clinical Trial Management System (CTMS) Migration team with communication strategy and creation of visuals to help employees understand their role in migration, resulting in increased team.
• Created a company presence for the SAS Cloud Migration Project. Developed the logo, SharePoint, Q&A Forum, Teams channel, and SAS Cloud User Guide on a short timeline with minimal direction and executive-level.
• Developed a system for measuring impact of Creative Projects, resulting in 90% efficiency and proper tracking of KPIs and project reach.

• Conduct initial protocol feasibility assessment and initial country selection analysis. Deliver protocol-specific country recommendations via data-driven insights. Lead local team to deliver pre-qualified sites.
• Led a team of Global Site Feasibility Liaisons, providing training and mentorship to drive 20% improvement in efficiency.
• Developed and maintained strong relationships with principal investigators, sponsors and clinical site staff resulting in a20% improvement in trial satisfaction.
• Increased enrollment by 15% on an inherited trial, with complicated sponsor requirements and specific inclusion criteria.
• Implemented process improvements to reduce feasibility timelines by 15%.
• Successfully led feasibility for 40 global trials with site counts ranging from 50- 600.

Morrisville, North Carolina, United States

• Liaise with Clinical Monitoring, Site Start Up, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
• Creates/Coordinate the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes.
• May support Site Feasibility Lead/Manager in working with client to obtain/agree to study specific Confidential Disclosure Agreement (CDAs) Template for a study.
• Distribute Confidential Disclosure Agreements (CDAs) and feasibility questionnaire to sites and follow up with sites accordingly to ascertain interest and to meet study timelines.
• May review and negotiate the CDAs according to country specific requirements, seeking legal/management review when required.
• Documents/escalates study challenges and communicates updates to Project Manager and SSU Lead/Management.

United States

• Update and maintain PI Database contact entries.
• Update and Maintain proprietary Infostart tracking Database
• Run reports and conduct searches for PI experience in the PI Database.
• Correspond with potential investigators and sites regarding study opportunities.
• Supports PI Database project lead on database improvement and data cleaning projects.
• Assist ISSC Leads and ISSC Managers with reports as needed.

Raleigh-Durham, North Carolina Area

Produce attractive and effective designs for all media, including print, website, ecommerce, email, social media and packaging. Liaise effectively with clients and other team membersCapture & edit photos for projects across various departments as neededManage studio props - inventory, ordering, and loggingManage marketing materials, including production.

• Schedule and screen eligible patients for research studies
• Conduct and Document follow ups and protocol specific testing and interviews
• Travel to various sites for study implementation
• Evaluate each site for study feasibility and monitor progress
• Train others to run the study and collect data to upload into EDC
• Troubleshoot data issues and provide support to team

• Register and schedule all new patients into the All scripts system.
• Input clinical documentation on behalf of the physician or medical director
• Documentation of patients encounters, medication lists, medical treatment, problem lists, prescriptions and referrals in Allscripts EMR and Allscripts PM.
• Scan and Index Documentation of patient insurance and demographic information.
• Medical record documentation. Accurately code the primary/secondary diagnoses
• ICD-10-CM and coding conventions.

RTP, NC

• Performing QA checks on Plasma test results According to cGMP guidelines.
• Processing Plasma Shipments for licensed and unlicensed plasma centers while following SOP's.
• Contacting Plasma centers and requesting documents for review.
• Updating Plasma shipment information via Company specific Database
• Indexing plasma batches by Vendor Number and Plasma Center.

RTP, NC

• Responsible for receiving CRFs sent in from clinical research sites and processing according to SOPs in a timely manner.
• Contacting Vendors as needed to obtain required documentation, and also to resolve outstanding DCF's
• Routine Q.C. Testing /Audits of test results and all projects according to cGMP
• guidelines
• Assist with user acceptance testing for study specific and core CDM applications
• Track CRFs and DCFs

Raleigh-Durham, North Carolina Area

• Responsible for clinical data review, edit check review and data clarifications on complex projects
• Responsible for query generation/resolution, coding of terms, and reconciliation activities to support the delivery of clinical data according to client quality Review of Case Report Forms
• Prepared forms for data entry as determined by review guidelines and standard department procedures.
• Document, resolve and integrate data queries.
• Completed all relevant audit trail materials, Assisted in performing database audit(s) with project database manager.
• ∙ Communicated/coordinate with team to ensure clean database.