Experience

Occlutech

• Sweden
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Sr. Clinical Project Manager

  • Jun 2022 - Present

  Remote Manage day to day activities for an IDE trial being conducted in the US. Oversee CRO in the activation of new sites.



Stryker

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Clinical Contracts Associate

  • Jul 2021 - May 2022

  Remote Negotiate and execute contract clinical trial language with national sites. Negotiate all sites’ budgets. Provide expertise to Study Teams to resolve contract/budget issues to move sites toward contract execution, created budget startup document to standardize cost across all studies, review and provide feedback on other legal agreements



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Contracts Associate II

  • Apr 2019 - Jul 2021

  Negotiated and executed research clinical trial budgets and contracts with national sites. Ensured language is consistent across all documents including the contract, budget, protocol, and informed consent. Provide regulatory guidance concerning informed consent language. Business Unit Champion for Neuromodulation Study Team providing contract and budget expertise on new and amended studies.



Precision Orthosurgical Management, LLC

• Chief Operating Officer

  • Jun 2018 - Apr 2019

  Pasadena, California Precision Orthosurgical Management is an orthopedic hardware device distributorship contracting with hospitals and surgery centers across Southern California. Manage daily operations including 15 sales representatives. Develop and negotiate contracts with physicians and hospital accounts, setting up payment terms for hospitals and invoice tracking. • Increased outstanding revenue by 70%.



Children's Hospital Los Angeles (CHLA)

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Associate Director

  • Aug 2016 - May 2018

  Greater Los Angeles Area Directed all strategic planning and financial aspects of clinical trials operations, including regulatory compliance culminating in 235 research studies in Hematology, Oncology, and Bone Marrow transplant clinical trials. Monitored budgetary and contractual issues, supervised a 47-member staff team, and reviewed study-specific Medicare coverage analysis to determine staffing and procedure cost estimates. Coordinated completion of project startup metrics, ensuring correct cost allocation… Show more Directed all strategic planning and financial aspects of clinical trials operations, including regulatory compliance culminating in 235 research studies in Hematology, Oncology, and Bone Marrow transplant clinical trials. Monitored budgetary and contractual issues, supervised a 47-member staff team, and reviewed study-specific Medicare coverage analysis to determine staffing and procedure cost estimates. Coordinated completion of project startup metrics, ensuring correct cost allocation. Prepared FDA applications including single patient IND requests, amendments, and follow-up reports, along with submission of annual accrual/protocol reporting. Oversaw team submissions of investigator initiated IND applications, including collating all NDA documents per compliance before submission for approval and conducted final review of applications prior to submission to the FDA. ♦ Secured completion of several industry and cooperative consortia sponsored protocol audits, including FDA audit, utilizing results to create corrective action plans. ♦ Initiated process improvements with a study feasibility checklist to determine likelihood of trial success, moving forward only with those trials identified with high success rates. Built efficiencies in metrics reporting, protocol, and chemotherapy order tracking spreadsheet. ♦ Capitalized on built relationships, enabling studies to receive faster evaluation review. ♦ Conducted ongoing training for staff with focus on how to partner with review boards. Show less



City of Hope

• United States
• Hospitals and Health Care
• 700 & Above Employee

• IRB Operations Manager

  • Jul 2014 - Aug 2016

  City of Hope Medical Center, Duarte, California Launched multiple process improvements decreasing IRB review time, including participation on development of electronic IRB submission platform system and launch. Voting member of biomedical committees and signatory official for all IRB correspondence. Supervisory responsibilities for team of six. ♦ Lead implementation of Human Research Subjects Protection program, including research protocol review. Assisted with protocol submission, review, and approval process. ♦ Designed mandatory… Show more Launched multiple process improvements decreasing IRB review time, including participation on development of electronic IRB submission platform system and launch. Voting member of biomedical committees and signatory official for all IRB correspondence. Supervisory responsibilities for team of six. ♦ Lead implementation of Human Research Subjects Protection program, including research protocol review. Assisted with protocol submission, review, and approval process. ♦ Designed mandatory staff study pre-review process resulting in fewer contingencies and higher approval rates, resulting in full IRB approval in under 30 days. ♦ Constructed external adverse event review policy, decreasing IRB review time and investigator submission time. Show less



University of Southern California

• United States
• Higher Education
• 700 & Above Employee

• Radiology Research Administrative Director

  • Mar 2010 - Jul 2014

  Increased research funding and infrastructure by over 30% due to key relationships built to decrease contract, budget, and IRB review time, thereby increasing study patient referrals and quicker resolve time, leading to USC becoming one of top recruiting sites for several clinical trials. Administered all financial aspects of research trials including budget planning, negotiations, billing, and allocations of funds. Lead team comprised of research coordinators, associates, students, and… Show more Increased research funding and infrastructure by over 30% due to key relationships built to decrease contract, budget, and IRB review time, thereby increasing study patient referrals and quicker resolve time, leading to USC becoming one of top recruiting sites for several clinical trials. Administered all financial aspects of research trials including budget planning, negotiations, billing, and allocations of funds. Lead team comprised of research coordinators, associates, students, and research nurses. Facilitated training on human subject regulations to staff and investigators. ♦ Merged department costs into additional department budgets, resulting in cost recovery increase of 25% as well as approximately $200K savings via subcontractor overcharges. ♦ Created salary pool through clinical trial enrollments to offset coordinator and investigator salary through a percentage collection from each sponsor payment resulting in positive cash flow for non-revenue-earning department. ♦ Navigated all budgets and negotiations of clinical trial contracts, improving payment schedules and reporting requirements. ♦ Streamlined research applications resulting in efficiencies to research process using in-depth knowledge of federal regulations and institutional policies and procedural requirements. ♦ Developed templates to streamline IRB submissions, resulting in improved efficiencies with fewer submission errors and studies approved 50% faster.

• Manager, Department of Clinical Trials Management

  • Jan 2008 - Mar 2010

  Liaised between sponsors and IRB to address any requests, negotiating budget and contract language, questioning regulatory requirements when necessary, and providing reasoning to adverse event reporting resulting in faster contract processing. Collaborated with Principal Investigators, Administrators, and Coordinators to appropriately determine either standard of care or research testing based on budget allocations, including Medicare coverage analysis. ♦ Built budget templates, ensuring… Show more Liaised between sponsors and IRB to address any requests, negotiating budget and contract language, questioning regulatory requirements when necessary, and providing reasoning to adverse event reporting resulting in faster contract processing. Collaborated with Principal Investigators, Administrators, and Coordinators to appropriately determine either standard of care or research testing based on budget allocations, including Medicare coverage analysis. ♦ Built budget templates, ensuring language consistency among all facets, including contract, budget, protocol, and informed consent. ♦ Facilitated onboarding trainings and orientation to Principal Investigators and Coordinators.

• IRB Director, Health Sciences Campus

  • May 2002 - Dec 2007

  Greater Los Angeles Area Increased staff by over 100% to decrease review time and improve response turnaround time. Created two additional committees to conduct reviews decreasing time to full committee review from 28 days to 14 days. Created a staff study pre-review process to identify issues sooner and lessen the likelihood of contingencies. ♦ Key contributor to the development and implementation of an electronic IRB submission platform system and created a robust user help guide.