Jessie Schultz
Tonganoxie,KS
Summary
Experienced Clinical Trial Specialist with 10+ years of clinical research expertise. Specializes in subject recruitment, study start-up, and recruitment management. Proficient in conducting trials in Neurology, Oncology, Musculoskeletal, and Respiratory fields. Conscientious self-starter excelling at prioritizing tasks to meet deadlines while remaining composed under pressure. Skilled in managing high-profile trials and leading study teams. Possesses strong coaching and mentoring abilities in both group and individual settings.
Overview
11
11
years of professional experience
Work History
Senior Clinical Trial Specialist
Advanced Clinical
05.2023 - 08.2024
- Managed Site Essential Documents review during study start-up, maintenance and close-out period
- Prepared study documents and manuals
- Ensured tracking of essential documents are received and filed in the TMF, reviewed site documents for accuracy; provides clinical team support with TMF filing and management
- Reviewed and approved trip reports, tracked data query reports, site visit metrics, and overall site performance
- Involved in organization of team and vendor meetings including preparation of agenda/ minute taking and updating any risk/ issue/ decision logs
- Assisted and supported data query process
Site Management Associate II
ICON Clinical Research
05.2019 - 05.2023
- Acted as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (pre-study, initiation, monitoring and close out visits)
- Completed essential document collection and reviewed throughout the study lifecycle, organizes and maintained site clinical trial master file (TMF) documents
- Performed off-site visits as needed to ensure sponsor and investigator obligations are being met and are compliant with applicable regulatory requirements and guidelines
- Provided training and mentoring to less experienced team members along with team leadership
- Assisted in management with the development of training materials
Clinical Trial Specialist II
PRA Health Sciences
08.2017 - 05.2019
- Mentored junior level staff and served as a resource for new employees
- Assisted with development and delivery of relevant training curriculum
- Participated in peer interviews and provides feedback to management regarding potential candidates
- Performed onsite investigator site file (ISF) review, as needed
- Co-monitored clinical trials to ensure sponsor and investigator obligations were being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines as needed.
Clinical Trial Specialist I
PRA Health Sciences
05.2016 - 08.2017
- Supported investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements
- Documented site and Sponsor contact and study interactions in a timely and professional manner
- Performed study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete
- Performed study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study
- Performed investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites
- Utilized the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked
- Provided quality review of the informed consent template
- Performed essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines
Recruitment Specialist I - EDS
PRA Health Sciences
09.2014 - 05.2016
- Trained recruitment and screening staff on identification population outlined in the protocol
- Managed recruitment and screening activities per protocol specific enrollment goals
- Prepared recruitment and screening documents to facilitate successful volunteer enrollment
- Worked directly with study volunteers scheduling lab appointments, answering questions, confirmation of admission and reminders/follow ups
- Worked with medical team and clinical study management to deliver qualified volunteers per protocol criteria
- Encouraged/lead staff to meeting recruited expectations for each particular protocol
Recruiter Associate I - EDS
PRA Health Sciences
06.2013 - 09.2014
- Answered and placed potential phone calls for interested study volunteers
- Ensured payment to the volunteers
- Performed outreach recruiting events as requested
- Explained study protocols to volunteers for each study during telephone screening
- Ensured maintenance and accuracy of recruiting database and performed database queries
- Worked as a member of the recruiting team to obtain sufficient numbers of qualified volunteers for each study.
- Conducted phone interviews to assess applicants relevant knowledge, skills, experience and aptitudes.
Education
No Degree - General Studies
University of Kansas
Lawrence, KS08-2010
No Degree -
Johnson County Community College
Overland Park, KS08-2011
Associate of Arts - Liberal Arts
Johnson County Community College
Overland Park, KS05-2019
Continuing Education - Communications
Ottawa University
Ottawa, Kansas08-2022
System Experience
- Siebel Clinical (CTMS)
- Aurora
- Medidata RAVE
- Oracle Inform
- Datalabs IVRS
- Veeva Vault eTMF
- NextDocs eTMF
- PhlexEview eTMF
Therapeutic Experience
- Cardio-Metabolic
- Musculoskeletal
- Neurology
- Oncology
- Psychiatry
- Respiratory
Certification
- CITI Training, current 2024
- GCP Training, current 2024
- I manage my own business on the side as a part time photographer and have had a successful experience. I create my own sets, manage clients, explore creativity, and manage my business professionally.
Timeline
Senior Clinical Trial Specialist
Advanced Clinical
05.2023 - 08.2024
Site Management Associate II
ICON Clinical Research
05.2019 - 05.2023
Clinical Trial Specialist II
PRA Health Sciences
08.2017 - 05.2019
Clinical Trial Specialist I
PRA Health Sciences
05.2016 - 08.2017
Recruitment Specialist I - EDS
PRA Health Sciences
09.2014 - 05.2016
Recruiter Associate I - EDS
PRA Health Sciences
06.2013 - 09.2014
No Degree - General Studies
University of Kansas
No Degree -
Johnson County Community College
Associate of Arts - Liberal Arts
Johnson County Community College
Continuing Education - Communications
Ottawa University