Nicole Rymarchyk

Experience

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  NSABP

  Jan 1993 - Aug 1995

  Research Specialist
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  OHSU Knight Cancer Institute

  Jan 1996 - Oct 2004

  Participated in the preparation of investigator-initiated protocols, FDA and IRB submissions, and research grantsManaged regulatory documents and performed site initiation and monitoring visits for investigator-initiated, multi-center clinical trialsDrafted the Data Safety Monitoring Plan, served as Lead QA Auditor, and coordinated activities of the OHSU Cancer Institute Data and Safety Monitoring CommitteeResponsible for regulatory management of molecular studies focusing on targeted therapies for cancer treatmentConducted research compliance training modules for investigators, CRAs, residents and fellowsDrafted OHSU Cancer Institute SOPs and work instructions Show less Prepared new studies for IRB review, coordinated weekly IRB meetings, took meeting minutes, and drafted IRB recommendations for investigatorsServed as resource to academic research community and IRB Committee members regarding FDA regulations and OHRP guidelines for research involving human subjectsParticipated in recruitment and training of new IRB members, and developed a continuing education program for the IRB CommitteeParticipated in committees to establish OHSU IRB policies for genetic studies, emergency research, placebo-controlled trials and equitable enrollment in research studiesCoordinated national OHRP conference held in Portland Show less

  • Research Compliance Specialist

    Jan 2000 - Oct 2004

  • Regulatory Manager, Druker Lab

    Jan 1998 - Oct 2004

  • IRB Analyst

    Jan 1996 - Jan 1998
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  BIOTRONIK, Inc

  Oct 2004 - Jan 2007

  Corporate Compliance Officer

  Scheduled and performed periodic internal audits of all company activities subject to FDA regulations including medical device reporting systems, product complaints, device tracking, clinical studies and external vendorsCoordinated activities of the Device Complaint Review and CAPA CommitteesAssisted in the preparation of regulatory submissions including IDEs and PMA supplements, and reviewed marketing materials and labeling for approved medical devicesLed the 15-member project team responsible for compiling annual reports to the FDA for marketed and IDE devices Participated in three FDA inspections and prepared written responses to inspection reports Drafted and implemented the BIOTRONIK Code of Business Conduct, and provided training to all in-house and national sales staff on ethical business practices Participated in creation and review of departmental SOPs, developed a comprehensive employee training program, and maintained employee training records Show less

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  Providence Health & Services

  Jan 2007 - now

  Responsible for developing and implementing a comprehensive quality assurance program for Providence Cancer Center and other research centers in the Oregon Region.

  • Quality Assurance Manager, Regional Research Office

    Jan 2010 - now

  • Quality Assurance Manager, Providence Cancer Center

    Jan 2007 - Jan 2010