Karrie Mitchell
Greeley,CO
Summary
Clinical research professional with 25+ years of experience, equipped to deliver high-quality results. Demonstrates strong analytical skills and precision in handling complex documents. Adept at collaborating within teams to meet dynamic needs and ensure compliance with regulations. Reliable and adaptable, known for maintaining high standards and driving successful outcomes.
Experience working remotely (home-base).
Overview
24
24
years of professional experience
Work History
Initiation Clinical Research Associate
Parexel International
02.2023 - Current
- Oversee the conduct of the trial at assigned site(s). Accountable for quality and delivery of site's regulatory documentation during the start-up phase.
- Building a positive working relationship with the site staff and ensure the conduct of the trial is in compliance with the protocol and/or amendment(s), with GCPs and applicable regulatory requirements where applicable.
- Manage multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines.
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate amendments.
- Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
- Responsible for Central Institutional Review Board submissions and review/filing of approval documents.
- Collaborated with trial teams/sponsors to provide occasional assistance with feasibility details and identification of potential trial sites.
- Achieve First Time Quality (FTQ) of startup documentation 95% or greater annually.
- Consistent positive feedback from colleagues highlighting attention to detail, work ethic and being a team player.
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Applied extensive GCP, ICH and FDA regulations knowledge to troubleshoot and resolve regulatory document issues.
Regulatory Document Reviewer
ExecuPharm/Parexel (FSP), Boehringer Ingelheim Pharmaceuticals, Inc.
07.2008 - 01.2023
- Primary regulatory contact for sites across Phase 1-4 trials, with varying disease indications.
- Worked with clinical trial sites on completion, collection of regulatory documents.
- Ensured sponsor and investigator obligations followed applicable local regulatory requirements, IRB and ICH/GCP and FDA guidelines from site selection to closure (i.e. 1572, investigators curriculum vitae (CV), financial disclosure forms, medical license, protocol signature page, lab certifications, training certifications).
- Performed quality and timely review of site and project level regulatory documentation.
- Reviewed, approved site-specific informed consent forms for submission, review by IRB of record.
- Provided real-time updates to sponsor trial teams regarding status of site start up, ongoing regulatory requirements, through site closure.
- Prepared and submitted project level central IRB submissions, from initial application through trial close-out.
- Provided sponsor trial team members with central IRB approval documentation; assisted with reviewing documentation for accuracy.
- Served as liaison between sponsor trial team members, central IRB representatives.
- Completed entries for project, site approvals in trial-specific databases.
- Collaborated with trial teams to provide occasional assistance with feasibility details and identification of potential trial sites.
- Performed QCs on documentation filed in sponsor electronic portal/hybrid ISF and Trial Master File.
- Mentored new hires as assigned.
- Provided detailed feedback on reviewed documents, contributing to continuous improvement efforts within the team.
- Reduced turnaround time for projects by effectively prioritizing tasks and managing deadlines.
- Obtained First Time Quality of start up and continuing project documents 95% or more for each project.
- Colleagues highlight strong work ethic, quick and efficient timelines, team player.
Regulatory Specialist
National Jewish Health
01.2003 - 09.2011
- Oversaw regulatory requirements for 40-60 trials at a time.
- Responsible for initiation, maintenance of all trial regulatory documents including 1572s, Financial Disclosure Forms, HIPAA forms, investigator CVs.
- Responsible for creation, submission of trial documentation to local IRB from start-up through closure.
- Liaison between Industry sponsors, Contract Research Organizations, local IRB, staff, physicians for current and future projects.
- Performed quality control reviews on all subject data prior to randomization, to verify protocol eligibility.
- Responsible for Internal monitoring of data collected for industry, investigator-initialed trials.
- Assisted physicians, fellows with writing of investigator-initiated protocols; filing and ongoing maintenance of INDs.
Education
Post-Graduate Coursework - Psychology
University of Northern Colorado
Greeley, COBachelor of Arts - Biopsychology
Hastings College
Hastings, NE05-1997
Skills
- Teamwork and collaboration
- Organization Skills
- Multitasking abilities
- Problem-solving aptitude
- Confidentiality awareness
- Adaptability and flexibility
- Current Good Clinical Practice Certification
- Certified Clinical Research Coordinator
- Member of Association of Clinical Research Professionals
Therapeutic Area Expertise
Capacity: Start Up and/or Ongoing Regulatory Activities
- Allergy/Immunology Phase II-IV; Investigator-Initiated
- Cardiology Phase II-III
- CNS Phase I-III
- Dermatology Phase I-III
- Gastrointestinal Phase II-III
- Infectious Diseases Phase I-III
- Metabolic Phase I-III
- Neurology Phase II-III
- Oncology Phase I-III
- Psychiatry Phase II-III
- Respiratory Phase I-IV
- Sleep Phase II-III; Investigator-Initiated
- Vaccine Phase II-III
Timeline
Initiation Clinical Research Associate
Parexel International
02.2023 - Current
Regulatory Document Reviewer
ExecuPharm/Parexel (FSP), Boehringer Ingelheim Pharmaceuticals, Inc.
07.2008 - 01.2023
Regulatory Specialist
National Jewish Health
01.2003 - 09.2011
Post-Graduate Coursework - Psychology
University of Northern Colorado
Bachelor of Arts - Biopsychology
Hastings College