Sherilyn Lindelien, MPH
Boise,ID
Summary
Senior Clinical Trial Coordinator with extensive experience in managing clinical trials across various therapeutic areas. Expertise in clinical trial protocols, patient recruitment, regulatory compliance, and data management. Recognized for enhancing trial efficiency and maintaining high ethical standards in previous roles. Strong communicator with a proven ability to collaborate effectively within cross-functional teams.
Overview
11
11
years of professional experience
Work History
Senior Clinical Trial Coordinator
Merck Sharp & Dohme
Boise, ID
02.2024 - Current
- Managed comprehensive trial and site administration, ensuring efficient preparation and distribution of clinical documents.
- Coordinated clinical trial activities across various therapeutic areas and phases.
- Facilitated communication among sponsors, investigators, and study sites to enhance collaboration.
- Supported clinical supply and non-clinical supply management through timely tracking and reporting maintenance.
- Performed data entry into electronic databases to maintain accurate tracking records.
- Organized training sessions for site personnel on trial procedures and compliance requirements.
- Reviewed essential documentation for study initiation and closeout activities to ensure regulatory adherence.
- Monitored patient enrollment status in clinical trials, ensuring compliance with FDA regulations and ICH guidelines.
In House CRA III
ICON PLC
Boise, ID
11.2020 - 02.2024
- Reviewed and verified data entries for accuracy in clinical databases.
- Facilitated communication among sponsors, sites, and regulatory bodies during trials.
- Participated in audits to ensure compliance with organizational standards.
- Analyzed collected data for accuracy before database lock; identified discrepancies when necessary.
- Tracked enrollment status across multiple sites to meet target goals on schedule.
- Maintained strict confidentiality of personal information and collected data.
- Ensured timely completion of deliverables by monitoring project timelines.
- Supported investigator selection by providing professional input based on expertise.
Systems Validation Specialist
PRA Health Sciences
Salt Lake City, UT
04.2017 - 11.2020
- Met regulatory compliance standards for documentation and validation results.
- Conducted validation protocols for clinical trials, ensuring adherence to regulations.
- Reviewed and approved validation documentation to align with regulatory requirements.
- Collaborated with cross-functional teams to maintain project timelines.
- Developed risk assessments to identify potential issues in validation processes.
- Facilitated training sessions on validation procedures for new team members.
- Monitored regulatory changes to update validation practices accordingly.
- Prepared reports summarizing validation results for internal stakeholders.
QC Associate
PRA Health Sciences
Salt Lake City, UT
03.2016 - 04.2017
- Monitored documentation practices to ensure high accuracy and regulatory compliance.
- Analyzed data to verify adherence to regulatory standards and protocols.
- Reviewed laboratory results for accuracy and compliance with specifications.
- Documented findings and maintained precise electronic records.
- Participated in internal audits to evaluate quality management system compliance.
- Supported training initiatives for new staff on quality control procedures.
- Collaborated with Quality Assurance team on continuous improvement of workflows and standards.
- Identified documentation error trends for proactive resolution.
Academic and Research Assistant
University of Utah School of Medicine
Salt Lake City, UT
10.2014 - 03.2016
- Submitted grant proposals and applications to IRB for research funding.
- Conducted literature reviews to enhance ongoing medical research projects.
- Assisted with data collection and entry for clinical studies.
- Coordinated meetings between researchers and study participants to facilitate communication.
- Prepared research materials and presentations for academic conferences.
- Managed multiple research projects, ensuring precise record keeping.
- Drafted manuscripts for submission to peer-reviewed journals.
- Coordinated resident education courses on head and neck and skull base dissection.
Education
Master of Science - Charles Town, WV
American Public University
Charles Town, WV05.2020
Bachelor of Science - Public Health
American Public University
Charles Town, WV10.2014
Skills
- Trial coordination and management
- Site administration and monitoring
- Project management
- Risk assessment
- Regulatory compliance
- Clinical research operations
- Stakeholder engagement
- ICH GCP adherence
- Study documentation accuracy
- Source document verification
Technical Proficiencies
Epic Systems, Veeva Vault, Electronic Data Capture systems, Power Apps, Microsoft Office Suite
References
References available upon request.
Timeline
Senior Clinical Trial Coordinator
Merck Sharp & Dohme
02.2024 - Current
In House CRA III
ICON PLC
11.2020 - 02.2024
Systems Validation Specialist
PRA Health Sciences
04.2017 - 11.2020
QC Associate
PRA Health Sciences
03.2016 - 04.2017
Academic and Research Assistant
University of Utah School of Medicine
10.2014 - 03.2016
Master of Science - Charles Town, WV
American Public University
Bachelor of Science - Public Health
American Public University