Experience

Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky

• United States
• Hospitals and Health Care
• 100 - 200 Employee

• Director of Regulatory Compliance

  • Oct 2021 - Present

  • Oversee the affiliate’s compliance with applicable state and federal laws, including (but not limited to) Anti-Kickback statutes, Stark Laws, 501(c)3 and 501(c)4 separation, telemedicine requirements, abortion regulations, and controlled substance handling; working with the appropriate stakeholders to ensure affiliate policies and procedures are current and in practice. • Researched and directed the execution of clinic policies that reflected maximization of clinician and healthcare… Show more • Oversee the affiliate’s compliance with applicable state and federal laws, including (but not limited to) Anti-Kickback statutes, Stark Laws, 501(c)3 and 501(c)4 separation, telemedicine requirements, abortion regulations, and controlled substance handling; working with the appropriate stakeholders to ensure affiliate policies and procedures are current and in practice. • Researched and directed the execution of clinic policies that reflected maximization of clinician and healthcare worker scope of practice across state lines, resulting in increased patient access while reducing operating costs. • Monitored state legislation from affiliate states and directed changes in our health centers for compliance, resulting in maintaining good standing for federal and state laws. • Approved all social media and marketing content for accuracy and compliance with 501(c)3 and 501(c)4 separation. • Developed and designed ethics and compliance training program for Board members; presented annual trainings and on an ad hoc basis. • Initiated a strategic alliance between outside Planned Parenthood affiliates and created a template for access collaboration agreements distributed to the entire Planned Parenthood Federation. The alliance affinity group established was held as the Federation standard of collaboration, and other affiliates were encouraged to mimic the model we created. • Conducted quarterly reports on Privacy violations, identifying trends and areas of weaknesses; presented findings to Directors and Vice Presidents. • Successfully identified and resolved gaps in patient privacy training, resulting in an update to our training program and a reduction of incidences of policy violations and contributing to an overall trend of declining incident reports. • Spearheaded telemedicine expansion in the current regulatory landscape resulting in the successful implementation of direct-to-patient telemedicine for mifepristone and misoprostol for three of our affiliate states.

• Interim Chief Legal Counsel

  • Jan 2022 - Aug 2022

  • Collaborating with the C-Suit and Medical Directors; appointed consultant and resource for outside counsel and litigators for cases where the affiliate is either plaintiff or defendant. • Evaluating the compliance landscape and with strategic cross-functional alliances, pivoting and making decisions that impact legal strategy and health center day-to-day management in all six affiliate states (Washington, Idaho, Alaska, Hawai’i, Indiana, Kentucky) resulting in maintaining and expanding… Show more • Collaborating with the C-Suit and Medical Directors; appointed consultant and resource for outside counsel and litigators for cases where the affiliate is either plaintiff or defendant. • Evaluating the compliance landscape and with strategic cross-functional alliances, pivoting and making decisions that impact legal strategy and health center day-to-day management in all six affiliate states (Washington, Idaho, Alaska, Hawai’i, Indiana, Kentucky) resulting in maintaining and expanding abortion where permissible and legal pathways for our patients to get care where impermissible. • As Privacy Officer, a head resource for HIPAA privacy matters, including providing technical assistance to staff regarding privacy concerns, and subject matter expert for fact-finding investigations for general allegations of noncompliance with the Privacy Rule. Successfully completed three federally instigated OCR investigations with no findings.



Planned Parenthood of the Great Northwest and the Hawaiian Islands

• Seattle, Washington

• Regulatory Compliance Counsel

  • May 2019 - Oct 2021



Swedish Cancer Institute

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

• Senior Federal Regulatory Affairs Coordinator

  • Feb 2018 - May 2019

  • Determined that no process existed for protocol deviation reporting for our clinical trial sites involved in NCI Community Oncology Research Programs (over 40 locations in our grant); established an efficient reporting process through a database system and conducted staff training. The capture of deviations resulted in identifying non-compliance in our program and led to mitigation. • Initiated and handled multiple Expanded Access Programs allowing otherwise ineligible cancer patients to… Show more • Determined that no process existed for protocol deviation reporting for our clinical trial sites involved in NCI Community Oncology Research Programs (over 40 locations in our grant); established an efficient reporting process through a database system and conducted staff training. The capture of deviations resulted in identifying non-compliance in our program and led to mitigation. • Initiated and handled multiple Expanded Access Programs allowing otherwise ineligible cancer patients to receive novel investigational product. • Lead support for the regulatory team of six members, with duties that included: researching and drafting responses for complex legal, billing, and compliance issues, document auditing for the team’s clinical trial portfolio, and study data management to be compliant with GDPR and HIPAA Privacy regulations in a clinical space. • Identified critical patient consenting and data errors in the longitudinal clinical trial. Organized data review of over 1,000 study participant charts to document mistakes. Presented an analysis to the IRB of the trial and errors and created a mitigation strategy with Principal Investigator that allowed him to continue in clinical research and ensure patient safety. • Executed the implementation of DocuSign in a clinical space, which required us to affirm CFR Part 11 Compliance with the FDA. In addition, using digital signatures significantly reduced document delays, creating a competitive study start-up time of around one month.

• Federal Regulatory Coordinator

  • Nov 2016 - Feb 2018



Providence Health & Services

• Hospitals and Health Care
• 700 & Above Employee

• IRB Coordinator

  • Apr 2016 - Nov 2016

  • Pre-reviewed protocols and other study documents for regulatory and institutional issues before items go to Expedited or Full Board Review; issued stipulations in a professional manner for documents that needed editing. • Researched regulatory issues encountered by the Institutional Review Office; drafted memos explaining the issue(s) and mitigation strategies. • Pre-reviewed protocols and other study documents for regulatory and institutional issues before items go to Expedited or Full Board Review; issued stipulations in a professional manner for documents that needed editing. • Researched regulatory issues encountered by the Institutional Review Office; drafted memos explaining the issue(s) and mitigation strategies.



Quorum Review IRB (Now Advarra)

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Editor, Regulatory Affairs

  • Aug 2015 - Apr 2016

  • Fact-checked, analyzed, and edited consent forms for compliance with state and federal rules and regulations and did not contain coercive, overly assuring, or undue influence language. • Presented the edited consent forms at Board Meetings, discussed the outstanding compliance issues that remained, and confirmed with the Board that the consent form was acceptable.

• Quality Control Specialist

  • Jan 2014 - Aug 2015

  • Document review for protocol and site level projects to ensure that documents going to the customer are as accurate as possible; analyze information from Docushare (database) and regulatory material to determine which data is required for the completion and delivery of the project; ensure accuracy of documents for Board Review so studies and sites are approved without delay • Initiated Quality Management Team’s (QMT) root cause analysis project which researched and analyzed errors… Show more • Document review for protocol and site level projects to ensure that documents going to the customer are as accurate as possible; analyze information from Docushare (database) and regulatory material to determine which data is required for the completion and delivery of the project; ensure accuracy of documents for Board Review so studies and sites are approved without delay • Initiated Quality Management Team’s (QMT) root cause analysis project which researched and analyzed errors identified in customer issued documents; final analysis included a memo that described the issue, where the error occurred (background), any trainings or procedures that could have prevented the error, and providing a conclusion as to how the error could be avoided in the future. • Created and implemented QMT’s successful engagement initiative to encourage collaboration and improved efficiencies across the teams that work with QMT • Target errors and spot trends in inaccuracies from various teams; train team members with a positive approach to improve their project accuracy; target inefficiencies in the quality process and provide feedback for process improvement • Collaborate with various team members to ensure compliance and customer satisfaction for document related material including: study consent forms, determination letters, ads, and site and protocol level notices



Lockheed Martin

• United States
• Defense and Space Manufacturing
• 700 & Above Employee

• Document Analyst

  • Mar 2011 - Jan 2014

  • Investigated potential Privacy and Security Rule violations, provided technical assistance to complainants and covered entities to resolve violations, and drafted letters of findings for the conclusion of investigations. • Investigated potential Privacy and Security Rule violations, provided technical assistance to complainants and covered entities to resolve violations, and drafted letters of findings for the conclusion of investigations.



Gregory Scott Hoover Law Firm

• Legal Intern

  • Nov 2010 - Jan 2011

  *Legal research within the Revised Code of Washington *Case briefing to promote efficiency in the office *Provided administrative support through mail outs, case organization, and general clerical and office work *Legal research within the Revised Code of Washington *Case briefing to promote efficiency in the office *Provided administrative support through mail outs, case organization, and general clerical and office work



Lowe's Companies, Inc.

• United States
• Retail
• 700 & Above Employee

• Customer Service Representative

  • Mar 2010 - Nov 2010

  *Provided customer oriented service in a high volume location by exceeding company standards for service and issue follow up *Worked under pressure with professionalism and customer focus *Supported managers through face to face and over the phone complaint resolution to reach customer satisfaction *Provided customer oriented service in a high volume location by exceeding company standards for service and issue follow up *Worked under pressure with professionalism and customer focus *Supported managers through face to face and over the phone complaint resolution to reach customer satisfaction