Summary
Overview
Work History
Education
Skills
Posterpresentations
Clinicalresearchstudies
Certification
Professionalsocieties
Currentposition
References
Timeline
Generic

Anne Kleinwolterink

Lenexa,KS

Summary

Efficient and focused professional in clinical research management. Known for high productivity and ability to complete tasks efficiently, ensuring timely project advancements. Skilled in patient recruitment strategies, regulatory compliance, and data analysis. Excel at communication, teamwork, and problem-solving to drive successful outcomes in complex research environments.

Overview

21
21
years of professional experience
1
1
Certification

Work History

Sr. Clinical Research Coordinator

Children's Mercy Hospitals and Clinics
Kansas City
08.2022 - Current
  • Developed and maintained regulatory documents for clinical trials.
  • Monitored study progress and documented adverse events in accordance with protocol guidelines.
  • Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
  • Trained new team members on the principles of Good Clinical Practice and ICH regulations.
  • Conducted pre-study site visits to assess compliance with protocols and applicable regulations.
  • Organized investigator meetings, prepared agendas, collected presentations, and took minutes at meetings.
  • Reviewed source documentation for accuracy of data entered into eCRFs.
  • Performed quality control checks on eCRF data by reviewing discrepancies reported by Data Management staff or generated from database queries.
  • Maintained accurate records of study documents including CRFs, informed consents, laboratory results.
  • Managed the development of study materials such as questionnaires or training manuals.
  • Collected, processed and delivered specimens from trial participants.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Monitored subject enrollment and tracked dropout details.

Clinical Trials Coordinator II

Children's Mercy Hospitals and Clinics
Kansas City
08.2015 - 08.2022

Clinical Trials Coordinator I

Children's Mercy Hospitals and Clinics
Kansas City
08.2013 - 08.2022

Perfusionist Assistant, Cardiothoracic Surgery

Children's Mercy Hospitals and Clinics
Kansas City
05.2013 - 08.2013

Emergency Nurse Technician

Children's Mercy Hospitals and Clinics
Kansas City
07.2003 - 05.2013

Education

BA -

The University of Kansas
Lawrence, Kansas
05.2011

Skills

  • Study monitoring
  • Protocol development
  • Patient recruitment
  • Trial management
  • Case report management
  • Research experience
  • Specimen collections
  • Phlebotomy
  • Informed consent
  • Study protocols
  • Participant screening
  • Trial oversight
  • Data collection techniques
  • Participant recruitment
  • Good clinical practices
  • Database organization

Posterpresentations

Kleinwolterink, A., Deculus, K., Selvarangan, R., New Vaccine Surveillance Network-Acute Respiratory Infection (NVSN-ARI) Refusal Rate Analysis-Inpatient vs. Emergency Department, CMH Research Day 2019, 2019

Clinicalresearchstudies

  • Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART), Clinical Research Coordinator, 2021-Present
  • Multi-level Intervention to Reduce Pregnancy Risk Among Adolescents, Clinical Research Coordinator, 2020-Present
  • Enhanced active surveillance of pediatric infectious diseases and vaccines Acute Gastroenteritis Group, Clinical Research Coordinator, 2013-Present
  • Enhanced Surveillance for New Vaccine Preventable Diseases - A Program Expansion for Acute Respiratory Illness Surveillance, Clinical Research Coordinator, 2016-Present
  • Adolescent Perspectives on Caregiver Notification after Disclosure of Adolescent Relationship Abuse, Clinical Research Coordinator, 2021
  • Evaluation of Accuracy and Ease of Use of the BioFire SpotFire Respiratory/Sore Throat Panel in a Near-Patient Setting DX-SDY-056666, Clinical Research Coordinator, 2021
  • Adaptation of the Healthcare Education Assessment and Response for Teen Relationships (HEART) Intervention for the Emergency Department (ED) Setting, Clinical Research Coordinator, 2020
  • Trends in Referrals to a Pediatric Eating Disorder Center, Clinical Research Coordinator, 2020
  • Parent-adolescent cultural conflicts and adolescent dating violence exposure: A survey-based study with Hispanic adolescent and their parents, Clinical Research Coordinator, 2020
  • Clinical Evaluation of the FilmArray GI Panel for use with Rectal Swabs Rev 05 DX-SDY044043, Clinical Research Coordinator, 2019
  • Adolescent Involvement with the Justice System and High-Risk Behaviors, Clinical Research Coordinator, 2019
  • Parent and Provider Views on Parent-Generated Asthma History in a Pediatric ED, Clinical Research Coordinator, 2019
  • Inpatient Adolescent and Young Adult Risk Survey Protocol, Children's Mercy Hospital, Kansas City, Clinical Research Coordinator, 2019
  • The Role of Contrast Enhanced Ultrasound to Diagnose Children with Appendicitis, Clinical Research Coordinator, 2018
  • Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing BioFire Study DX-SDY-038534, Clinical Research Coordinator, 2018
  • Identification of Adolescent Relationship Abuse in the Pediatric Emergency Department, Clinical Research Coordinator, 2018
  • RIDA Norovirus study, Clinical Research Coordinator, 2018
  • Evaluation and Comparison of Flu Detection Systems Alere LIAT, Clinical Research Coordinator, 2018
  • Prospective Study for Clinical Validation of the Molecular-Based GenePOC Strep A, C/G assay for the Detection and identification of Group A β-hemolytic Streptococcus and pyogenic Group C and G β-hemolytic Streptococcus nucleic acids from throat swab samples obtained from patients with signs and symptoms of pharyngitis., Clinical Research Coordinator, 2018
  • Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study GPCO03-002, Clinical Research Coordinator, 2018
  • Novel Computerized Decision Support System to Increase Access to Sexual Health Services for Adolescents in the Emergency Department, Clinical Research Coordinator, 2017-2019
  • BioFire Diagnostics, LLC Sponsor's Protocol Pilot Evaluation of the FilmArray Childhood Systemic Infection (CSI) Panel, Clinical Research Coordinator, 2017
  • ARIES Group A Streptococcus Multi-Site Clinical Study - Addendum, Clinical Research Coordinator, 2017
  • Use of Outpatient Opioids Prescribed from a Pediatric Acute Care Setting, Clinical Research Coordinator, 2016
  • Clinical Evaluation of the Xpress Flu/RSV and Xpress Flu A/B Assays on the GeneXpert Dx Instrument Systems in the Moderately Complex Environment, Clinical Research Coordinator, 2016
  • Pilot Evaluation of the FilmArray Febrile Infant (FI) Panel, Clinical Research Coordinator, 2016
  • A Randomized Controlled Trial of Asthma Action Plans in an Urban Pediatric Emergency Department, Clinical Research Coordinator, 2016
  • Evaluation of the Clinical Performance of the Alere iRSV Test, Clinical Research Coordinator, 2015
  • Trust and Privacy in the Pediatric Emergency Department, Clinical Research Coordinator, 2015
  • Do Emergency Medicine providers correctly identify parental worry?, Clinical Research Coordinator, 2015
  • Clinical Evaluation of an Improved BinaxNOW Influenza A&B Card, Clinical Research Coordinator, 2014
  • Evaluation of the Clinical Performance of the iNAT System for the Detection of Influenza A&B, Clinical Research Coordinator, 2013
  • Family Challenges & Strengths Survey (PILOT), Clinical Research Coordinator, 2013

Certification

  • ACRP CCRC, 10/13/15, 11/30/23
  • CITI Training, 10/27/22, 10/26/25
  • Basic Life Support, 07/23, 07/25
  • FEMA-Emergency Management Institution Program, 05/06

Professionalsocieties

  • Association of Clinical Research Professionals, 2015-Present
  • Heartland Association of Research Professionals, 2013-Present
  • The Society of Clinical Research Associates, Inc, 2015-Present

Currentposition

Children's Mercy Hospitals and Clinics, Kansas City, MO, Sr. Clinical Research Coordinator, 08/22, Current, Clinical Trials Coordinator II, 08/15, 08/22, Clinical Trials Coordinator I, 08/13, 08/15, Perfusionist Assistant, Cardiothoracic Surgery, 05/13, 08/13, Emergency Nurse Technician, 07/03, 05/13

References

References available upon request.

Timeline

Sr. Clinical Research Coordinator

Children's Mercy Hospitals and Clinics
08.2022 - Current

Clinical Trials Coordinator II

Children's Mercy Hospitals and Clinics
08.2015 - 08.2022

Clinical Trials Coordinator I

Children's Mercy Hospitals and Clinics
08.2013 - 08.2022

Perfusionist Assistant, Cardiothoracic Surgery

Children's Mercy Hospitals and Clinics
05.2013 - 08.2013

Emergency Nurse Technician

Children's Mercy Hospitals and Clinics
07.2003 - 05.2013

BA -

The University of Kansas
Anne Kleinwolterink