Kris L. Guthrie
Nazareth,PA
Summary
Dynamic Clinical Scientist with extensive experience at Parexel International, specializing in oncology and cardiology clinical trials. Proven track record in enhancing data accuracy and efficiency through innovative protocols. Skilled in statistical analysis and cross-functional collaboration, ensuring compliance and timely project delivery. Adept at managing complex imaging data reconciliation and fostering team communication.
Systems/Computer skills include: Microsoft Office (Excel, Word, PowerPoint, Outlook, Teams), Citrix, WebEx, MIRA, InForm, and JReview.
Knowledge of FDA Regulations, GCP and ICH.
Overview
2026
2026
years of professional experience
1
1
Certification
Work History
Clinical Scientist
Parexel International
Pennsylvania, USA
2020 - Current
- Conducted clinical trials to evaluate drug safety and efficacy, ensuring compliance with regulatory standards.
- Implemented study protocols, enhancing data collection efficiency and accuracy.
- Collaborated with cross-functional teams to address scientific queries and resolve study issues promptly.
- Analyzed complex clinical data using statistical software, facilitating informed decision-making for project stakeholders.
- Expert in the reconciliation process of clinical trial imaging data.
- Managed the imaging query process in project database as well as the imaging data discrepancies from the imaging vendor.
- Performed medical monitoring activities including review of Protocol Deviations, Adverse Events, Subject eligibility, and Missing Visit follow up.
- Maintained vendor Verification of Recurrence results, Patient Status, and Non-Emergency Unblinding trackers.
- Supported Interim analysis and Database lock activities.
- Assisted with reconciliation of Radiation therapy data with vendor and Data Management.
Lab Data Coordinator
Parexel International
Pennsylvania, USA
2016 - 2020
- Coordinated data collection and management processes to ensure timely project delivery.
- Developed and maintained databases for accurate tracking of clinical trial information.
- Streamlined data entry procedures, enhancing accuracy and reducing processing time.
- Collaborated with cross-functional teams to support project planning and execution strategies.
- Performed imaging data reconciliation.
- Managed imaging data query and resolution process in both client and vendor database.
- Provided metrics to study team on status of imaging data.
- Contributed to the success of Database locks ensuring all imaging received on time and as required.
- Extracted data from client database and created reports for Lead Clinical Scientist in preparation for Medical Monitoring review and presentation during Medical Monitoring Meetings.
- Assisted Lead Clinical Scientist with data cleaning for Interim analysis and Database locks.
Imaging Specialist
ICON Plc
Pennsylvania, USA
2008 - 2016
- Performed Image Processing and Image Quality Assurance in accordance with study specific guidelines.
- Worked directly with Core Lab Operations and Project Managers providing imaging expertise and support for client specific activities.
- Conducted site Imaging Manual Training calls in support of study site training.
- Served as Monitor for Independent Analysis Sessions.
- Collaborated with healthcare professionals to ensure accurate imaging protocols.
- Assisted Project Manager with development of project specific Procedure Manual.
- Provided technical support for business development.
Nuclear Medicine Technologist
Advanced Radiology and Cardiovascular Center
Easton, PA
2003 - 2008
Education
Bachelor of Science - Nuclear Medicine Technology
Cedar Crest College
Allentown, PASkills
- Therapeutic area experience in clinical research (phases II and III) includes: Oncology - Esophageal Cancer, Gastric Cancer, Colorectal Cancer, Head and Neck Cancer, Brain Cancer, Breast Cancer, Non-Small Cell Lung Cancer, Melanoma, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, B-Cell Lymphoma, Cutaneous T-Cell Lymphoma, Pancreatic Cancer, Prostate Cancer, Renal Cancer, Solid Tumors, Advanced Malignancies
- Cardiology - Dilated Cardiomyopathy, Heart Failure, Myocardial Perfusion Imaging
- Alzheimer's Disease, Respiratory Syncytial Virus, and Radiopharmaceuticals
- Experience in Start-up, Study Conduct, and Close-out
Certification
- Certified Nuclear Medicine Technologist, The Nuclear Medicine Technology Certification Board
Timeline
Clinical Scientist
Parexel International
2020 - Current
Lab Data Coordinator
Parexel International
2016 - 2020
Imaging Specialist
ICON Plc
2008 - 2016
Nuclear Medicine Technologist
Advanced Radiology and Cardiovascular Center
2003 - 2008
Bachelor of Science - Nuclear Medicine Technology
Cedar Crest College