Experience

Mary Crowley Cancer Research

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Program Manager, Clinical Trial Development

  • Oct 2017 - Present

  Coordinate with multiple functional areas within the Mary Crowley Cancer Research (MCCR) network such as Clinical Operations, Regulatory Submissions, and Contracting to oversee the selection and activation of early phase oncology trials• Reviewed over 200 protocols per year to achieve annual goal of 40 new trials• Diversified the existing solid tumor-focused MCCR trial portfolio to include hematology, rare diseases, and pediatric trials• Shorten overall start up timelines by decreasing feasibility and site qualification timelines by over 50%• Facilitated cross-company process enhancements, including new central IRB relationships, to streamline operations enabling trial initiation within 2 weeks from selection to enrollment• Built relationships with over 120 new sponsors, ranging from large pharma to small biotech • Organized MCCR company overhaul of the Standard Operating Procedures to consolidate, restructure, and align with industry. Show less

• Project Management and Development Associate

  • Jul 2016 - Dec 2018

  Coordinated regulatory submissions for over 25 Phase I-III oncology trials from site selection through IRB/IBC closeout• Collaborated on over 750+ local IRB submissions inclusive of new trial subs, protocol amendments, IB updates, and ICF alterations.• Helped restructure staff roles and dept tools to allow for 30% increase in studies managed, without increasing department’s annual budget• Created necessary documentation associated with required regulatory, Institutional Review Board, and Institutional Biosafety Committee submissions• Streamlined tool development process, regulatory submission process and management effectiveness via technology implementations Show less

• Data Coordinator

  • Mar 2015 - Jul 2016

  • Worked closely with investigators, coordinators, and study nurses across multiple clinical sites to clean and ensure quality control of source data• Performed Case Report Form data entry for over 50 Phase I-III oncology trials