• Oversaw access control for team members to SharePoint, eTMF, and training portals• Maintained site and contact details within Sitero CTMS and BSI CTMS• Generated Monitoring Visit (MVR) and Protocol Deviation reports• Coordinated preparation and shipment of Investigator Site Files and Pharmacy Manuals• Supported CTM with site follow-ups for questionnaire completeness• Shadowed In-House CRA for enhanced monitoring insights since June 2024

PPG Consultant representing Guardant Health• Managed Veeva Vault for document archival and closeout per SOPs and sponsor requirements• Compiled reports and metrics using eTMF, CTMS, and SharePoint• Conducted document migrations and quality checks in Rave RCM Medidata

• Supported project planning for site feasibility, selection, and activation• Collected, reviewed, and archived essential documents for TMF accuracy• Assisted in vendor management and audit readiness

Worked on Phase 1 studying Advanced Malignancies with ATRi Sensitivity.• Developed study-specific recruitment plans, retention materials, and newsletters• Maintained Important Protocol Deviation (IPD) lists• Managed informed consent form (ICF) review, versioning, and distribution• Set up training documents and maintained them in ZenQMS

• Tracked and disseminated regulatory documents• Managed study-specific contracts and clinical study payments in Greenphire• Assisted with development and distribution of electronic site binders

• Resolved registry quality management and clinical study report queries in EDC• Contacted Investigators and Study Coordinators to enter and sign visit pages• Submitted IRB documents for approval and managed trial master file systems• Participated in Employee Engagement Committee and planned educational meetings

• Processed billing submissions, reviewed insurance EOBs, and managed appeals• Resolved billing errors and resubmitted claims to insurance carriers

• Tracked IRB renewal dates• Maintained clinical trial monitoring/management tracking systems - Siebel Clinical, Salesforce, Oracle Clinical, Remote Data Capture and Electronic Data Capture• Enrolled new patients into studies by communicating with Study Coordinators and Project Managers• Member of Employee Advisory Committee and Volunteer Committees includes volunteering for The Ronald McDonald House, The Hope House and Habitat for Humanity

• Entered, updated and queried database CRFs• Reviewed, validated and resolved entry issues by conducting consistency checks with CRFs and actively managing query processes• Developed Data Clarification Forms (DCFs)• Provided ICD-9 or CPT coding for Case Report Forms before data entry

• Supported claims adjusters by ordering police reports and paying invoices• Requested wage loss information for claims resolution

• Designed and set–up study databases• Coded controlled documents with ICD-9 or CPT codes prior to entry • Performed quality checks on other data processors, database validations and internal audits to ensure data is accurately recorded• Maintained 12,000 keystrokes per hour with minimal errors

Paid or denied Tenncare claims within required timelinesWorked reports as neededFiled archives decreasing in Julian Date order

• Entered Nursing Home Grant applications while maintaining high accuracy and productivity• Called Investigators/providers of nursing homes to check on the status of the patient applications

• Provided ICD-9 or CPT coding for Case Report Forms before data entry then entered and edited data into a database

• Paid or denied Medicaid claims maintaining accuracy and productivity• Researched and verified audit trails

Maintained Claims control records by filing batches decreasing in Julian date orderPulled pend sheets to prepare for claims resolutions to key