Jessica Gitchell has over 4 years of experience in clinical research. She has worked as a Clinical Research Support Specialist and Data Coordinator. She has experience in study execution, data management, document management, and ensuring compliance. She has created new procedures and tools to improve efficiency.

1. Jessica Gitchell
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Summary
 ~4 years of experience in clinical research
 Certified in GCP/ICH,GDP, Informed Consent/HIPAA, and many databases/systems
 Familiar with general study execution/administration, data management, and document mgmt.
 Experience with many therapies over various trial phases at both the site and sponsor level
Accomplishments
 Created and implemented new procedures for the department, acting as sole Subject Matter
Expert and gaining Super User/Admin rights via membership in select Corporate groups
 Maximized efficiency by creating new tracking forms, assigning tasks to other employees, and
developing systematic data entry, verification, and cleaning procedures
 Alerted PI,subject liaisons, and database developer to trending discrepancies between data sets,
explained causes,and presented solutions that resulted in testing battery, data coding, and
software changes study-wide
ProfessionalExperience
Clinical ResearchSupport Specialist – Site Mgmt. Nov. 2014 to Present
Medtronic – Fridley, MN
- Supporting Continued Access, Post Market,and Surveillance studies for multiple therapies
 Ensuring accuracy and completeness of study documents in adherence to Protocols, SOPs,GCP,
etc.
 Filing study documents into paper and electronic systems,as well as routine
cleaning/maintenance of these systems
 Fulfilling ad hoc report requests, administrative needs, and record checks
 Tracking IRB approval status as well as overall study status at each site, monitoring changes and
setting forth additional actions as needed by MDT Study Team, Monitors, site contacts, or IRB
 Performing various Site Management, Monitoring, and Quality & Compliance functions:
overseeing documentation of protocol transfers,site activations, enrollments, IRB
Correspondences,Informed Consent and HIPAA,site visits, personnel changes, general study
communications, internal and external training, any holds or suspensions, and site closures
 Setting up accounts,sites, IRBs,Hospitals/Clinics, and study contacts in paper and electronic
Trial Master Files, Clinical Trial Management Systems, and Regulatory Affairs Domains
 Creating User Guides/Job Aids/Business Efficiency Tools and training the department on key
policies and procedures as they relate to the functionality of multiple systems used by internal,
corporate, and other cross functional teams
 Participating in Site Management, Business Milestone, and Data Quality meetings to
communicate study priorities, upcoming milestones, compliance rates,database freezes,new
procedures, areas of concern/improvement, etc.
 Supporting large scale database conversions and global harmonization efforts
 Audit prep and execution: worked closely with Managers,Quality, and Auditors to prep entire
department for back room efficiency while personally being a front room SME
- Representing department in enterprise-wide meetings on Regulatory Affairs Domain and
Clinical Trial Management Systems
 Relaying concerns,strategies, and general procedures to other business units and Corporate to
spread awareness and ensure standardization across Medtronic, globally
 Creating and implementing new department processes to align with corporate-level decisions

2.  Ensuring compliance with SOPs,CIPs,DMPs,and Clinical Strategies as overall Document
Management Subject Matter Expert, Clinical Trial Management System SME, and department’s
only Regulatory Affairs Domain SME, Super User,and Administrator
 Ad-hoc report building and record updating as requested by Corporate Quality and Compliance,
Clinical Safety, Monitoring, Data Management,Business System Analysis, and other teams
across Medtronic
 Working with SMEs from other business units to develop Business Efficiency Tools for use
across the enterprise globally
Data Coordinator May 2011 to Aug. 2012
University of Iowa College of Nursing – Iowa City,IA
-Organizing, Entering, Verifying, Analyzing, Problem Solving, and Presenting Data
 Utilizing REDCap,SPSS, Microsoft Word, PowerPoint, Access,and Excel.
 Finding, organizing, and transferring paper publications to digital files
 Making copies and scans of data for additional purposes/personnel
 Training people to work with data and to the study at large
 Overseeing the progress of data entry and verification: assigning work and completion deadlines,
double checking accuracy,and presenting progress/subsequent findings at lab meetings
 Subject tracking (recruitment status,informed consent, subject visits, interview schedules, etc.)
 Investigating lost or inconsistent data and making recommendations towards workarounds
 Sorting and cataloging recruitment sites and subject demographics
 Addressing discrepancies between subject and study data, testing batteries, how data is recorded,
and discussing how that does or does not align within the framework of a specified data program
- Other Responsibilities
 Regularly discussing and being up to date on recruitment efforts,subject visits, interview
schedules, and the health status of participants
 Attending meetings to give and receive updates, take minutes, and relay info to absent parties
 Referencing clinical report forms, informed consent documents, and other source records
 Making the schedules, tables, and forms necessary to keep all lab objectives easily accomplished,
tracked, user friendly, and accessible to all other staff
ResearchAssistant Jan. 2009 to Jan. 2010
Center for the Study of Group Processes – Iowa City, IA
 Collecting, entering, and verifying data
 Researching, reviewing, and writing literature reviews
 Proofing theses and making editorial suggestions to authors
 Brainstorming and problem solving past, current, and future studies
 Developing physical and electronic presentations of past studies for exhibition at conferences
Education
Bachelor of Arts: Psychology, 2012
University ofIowa – Iowa City, IA, United States of America
 Dean’s list student with minors in Neuroscience,Sociology, and Gender/Women’s/Sexuality Studies
Highlights
 Meticulous attention to detail
 MS Office proficient
 Adept communicator and problem solver
 Fast learner and self-directed
 Excellent at process improvement