Created protocol-driven study-specific Informed Consent templates throughout the life cycle of a trial by extrapolating info from study protocols and amendments, IBs, package inserts, budgets and contracts to produce final templates for distribution to U.S. study sites and central IRBs. Worked with cross-functional stakeholders to ensure understanding of timelines to develop quality documents and participates in team meetings.

Study site activation, with continued follow up for ongoing maintenance through study close out, with a focus on oncology studies. Responsible for projecting start up timelines in weekly updates to the project teams for an average workload of 50+ sites across different therapeutic areas. Distributed collected, reviewed and approved all essential regulatory documents for selected sites and collaborated with study personnel to draft informed consents for IRB submission and review. Worked to help resolve IRB stipulations and questions, escalating to legal or medical as appropriate. Expert in successfully working with research sites to collaboratively negotiate patient-centric consent forms that follow FDA/GCP/ICH regulations and guidelines as well as company SOPs and institutional requirements. Reviewed site budgets and contracts to confirm correct ICF stipend amounts and injury language. Conducted training for new hires. Ability to tailor presentations to an audience and communicate valuable guidance in a positive manner.

Helped create and define the responsibilities for the novel Regulatory Document Reviewer position at BIPI. Participated in a pilot project which resulted in expansion of the RDR role becoming the regulatory contact for the duration of a trial.

Independent Consultant providing pharmaceutical companies and CROs clinical trial monitoring, data management, and quality assurance services.

Responsible for research site monitoring and management for sites located in Texas, Oklahoma, Arkansas, Louisiana and other areas as needed.

Directed multi center clinical research studies by assisting the sponsor with protocol and CRF development, CRA oversight, central IRB submissions and Investigator Meeting presentations.

Conducted site management for numerous sites across the country in multiple therapeutic areas. Monitored Phase 1-4 clinical trials.