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Work experience

Aug 2009Present

Regulatory Affairs Coordinator

  • Facilitate the Institute for Integration of Medicine and Science (IIMS) researchers’ navigation through the complex regulatory requirements for research approval for conducting translational research involving either human participants in clinical research or use of animal models.
  • Provide education and training to investigators and research staff on ethics and regulatory requirements for conducting research.
  • Communicate regulatory processes and procedures to external partner organizations as well as to Health Science Center investigators and staff.  
  • Assist and support the Regulatory Key Function activities of the Clinical and Translational Science Award (CTSA) program in the development of regulatory infrastructure pathways and processes for research application and submission for required regulatory committee approvals to include IRB, IACUC, IBC, and Radiation Safety.
  • Work collaboratively with the Office of Clinical Research and IACP offices to coordinate and harmonize procedures.
  • Assist the Single Point of Contact (SPOC) program in creating and providing web site information and access to policy guidance and required submission forms.
  • Attend IRB meetings and work collaboratively with the IRB to develop policies and procedures to streamline the protocol approval process.
  • Author and edit new Standard Operating Procedures for investigators and research staff regarding regulatory issues pertaining to human subject research protection and animal research.
  • Participate in development and delivery of online and live educational programs and workshops on the conduct of ethical research in human participants or that using an animal model.
  • Work with the Research Subject Advocate on compliance issues and other human subject protection activities.
  • Consult with individual investigators and research staff on specific research projects regarding services available through the IIMS as well as applicable regulatory requirements.
  • Assist with the development of inter-institutional agreements of various types with partner organizations regarding regulatory and compliance activities and responsibilities.
Oct 2006Jun 2009

Medical Writer

  • Wrote clinical study protocols referring to current research and regulatory guidelines, including ICH, FDA, and GCP Guidances.
  • Interpreted complex data output from a broad range of scientific disciplines and authored Phase I/II clinical study reports (CSRs) and statistical reports using AMA style.
  • Wrote and edited CSR addendum for an international acute leukemia study.
  • Analyzed data listings for patients who violated or deviated from the protocol.
  • Edited statistical reports for clarity and accuracy, and verified statistical interpretation of the data.
  • Coordinated peer review of CSR and protocol drafts and amendments; incorporated review comments; obtained information from team members as needed to address review issues.
  • Wrote sections of investigational drug brochures, summarized animal and clinical studies, and drew conclusions as to the potential safety of the study drug.
  • Assisted in writing regulatory documents, including annual reports, investigational new drug applications, and new drug applications.
  • Translated and synthesized clinical data to write comprehensive safety narratives.
  • Verified scientific accuracy of publications by data checking information against the original source.
  • Created, edited, and formatted slide presentations.
  • Consulted with sponsors to address issues and to determine format, design, and direction for documents.
  • Consistently met stringent deadlines to produce quality documents within specified timelines.
  • Edited and performed quality control review of documents prepared by other medical writers.
  • Ensured adequate review of documents according to Standard Operating Procedures.
  • Provided weekly status updates to departmental management for all assigned studies.

Additional Skills

  • Detail-oriented with excellent ability to prioritize and to work with minimal supervision.
  • Worked successfully from home full time.
  • Experienced in both Phase I and Phase II-IV clinical studies.
  • Excellent grammatical and communication skills; adaptable and flexible in nature; efficiently managed multiple priorities simultaneously.
  • Highly proficient in Microsoft Office with superior word processing skills.
Aug 2001Oct 2006

Protocol Coordinator

Southwest Oncology Group (SWOG)
  • Coordinated all aspects of Southwest Oncology Group clinical research protocols from initial concept to study completion, working collaboratively with other members of the study team, including Principal Investigators, Study Coordinators, Industry Sponsors, Biostatisticians, Medical Monitors, Clinical Research Associates, and Quality Assurance Auditors.
  • Wrote and edited concepts, letters of intent (LOIs), full protocols, model informed consent forms, institutional review board (IRB) and National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) correspondence.
  • Served as subject matter expert for leukemia, myeloma, bone marrow transplantation, and immunomolecular therapeutics protocols and disease information.
  • Developed new protocols concurrently for assigned disease committees (approximately 15-20 studies at a time) and activated 5-7 new protocols per year.
  • Monitored active protocol documents and wrote amendments as needed.
  • Coordinated peer review of protocol drafts and amendments; incorporated review comments; obtained information from team members as needed to address review issues.
  • Served as a liaison between the National Institutes of Health (NIH)/NCI/CTEP and the protocol team; revised the protocol based on NIH/NCI/CTEP and Central IRB review; wrote point-by-point responses to IRB and NIH review comments.
  • Content-edited manuscripts submitted by outside authors.
  • Wrote and submitted needs assessments for grant proposals.
  • Consistently met stringent deadlines to produce accurate documents within specified timelines.
  • Reviewed protocols and documents written by others for consistency and clarity.
  • Monitored and maintained contents of assigned protocol sections of the Group’s web site.
  • Attended departmental staff meetings and semi-annual Southwest Oncology Group meetings and provided status updates for all assigned studies.
  • Created meeting agendas and led monthly teleconferences for assigned committees.
  • Served as a general information resource for all disease committees and protocol teams and responded to health authority questions and requests.
  • Created and maintained active listing of approved bone marrow transplantation centers and updated listing in real time as new centers obtained approval or underwent approval status changes.



Skilled medical writer and editor with 8 years of clinical trials experience producing quality deliverables (including protocols, clinical study reports, Investigator Brochures, Annual Reports, and patient  safety narratives), working within stringent timelines, and developing and maintaining client relationships to provide high-quality results.


Honors/Professional Memberships

  • American Medical Writers Association, member since 2007
  • Phi Beta Kappa, Theta Chapter of Illinois, member since April 1997
  • Baxter Foundation Scholarship Recipient, 1994-1997
  • Dean’s List, Lake Forest College, 1993-1997
  • Beta Beta Beta Biological Honor Society, member since 1994
  • Richter Apprentice Scholar, Lake Forest College, 1993-1994