Clinical Research Coordinator
Resume:
Melissa Krueger
Over ** years of clinical research experience including Research Assistant, Clinical Research Coordinator, Team Lead Research Coordinator, and Clinical Research Associate. SoCRA certified. Experience with Phase I-IV trials. Areas of therapeutic knowledge include Rheumatology, Podiatry (wound care) and Oncology.
25330 Silver Aspen Way
Stevenson Ranch, CA 91381
*******.*******@*****.***
EXPERIENCE
Old Navy — Retail Sales Associate
April 2025 - Present
Acknowledge and assist customers
Locating merchandise efficiently
Offer style and outfit suggestions to customers using mannequins and displays for inspiration
Promote customer loyalty by educating customers about loyalty programs Support sales floor, fitting room, checkout, and back of house processes as required
ICON, Sponsor-Dedicated to Janssen (Oncology)— Clinical Research Associate I
July 2021 - August 2023
Janssen SME - Site Manager OneNote Templates
Janssen SME - USOR
Facilitates audits and audit resolution
Serves as observation visit leader
Ensures all required training is completed and documented
Updates applicable tracking systems
Communicates with investigative sites
Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
Assesses IP accountability, dispensation, and compliance at the investigative sites
Performs source document verification and query resolution
Performs essential document site file reconciliation
Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
Completes monitoring activity documents as required by PRA SOPs or other contractual obligations
Provides regular site status information to team members, trial management, and updates trial management tools
Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
Working with external IRBs for amendment submission(s)
OHSU (Oncology GU), Portland, OR — Clinical Research Coordinator Team Lead
April 2021 - July 2021
Trial feasibility
Invoicing
Processing and shipping specimen
Performing ECGs
Obtaining patient vitals
Assessing patient reported outcomes
Consenting patients
Patient recruitment
Coordinating for Phase I, Phase II, Phase III, Phase IV and IITs
Project management
Acting daily manager and escalate issues to Clinical Research Manager when necessary
Training new staff
OHSU (Oncology CHO), Portland, OR — Senior Clinical Research Coordinator
October 2018 - April 2021
Assisting other groups across the Knight Cancer Institute
Trial feasibility
Point person for CROs in both investigator- and sponsor-initiated trials
Invoicing
Shipping specimen
Performing ECGs
Obtaining patient vitals
Assessing patient reported outcomes
Consenting patients
Patient recruitment
Project management
Training new staff
ExamOne, Beaverton, OR — Rep. Mobile Examiner
October 2018 – April 2021
Perform medical examines for life Insurance companies which Includes:
Venipuncture
Vitals
Obtaining medical histories
Obtaining updated medication lists
EKGs
Height/weight
Any special requirements needed
UCSF (Rheumatology), San Francisco, CA — Clinical Research Coordinator
June 2016 - October 2018
Assisting with overall trial logistics for both pharmaceutical- and investigator-initiated research trials
Invoicing
Patient recruitment through social media
Creating and managing specimen database
Preparing presentation data
Processing, banking, and shipping specimen
Patient reimbursements
Start-up activities for observational and clinical trials
Data entry
Obtaining patient vitals
Performing venipuncture in adult and elderly patients
Assessing patient reported outcomes
Scheduling and performing patient visits
Managing regulatory items for multiple studies
Training staff
Submissions to the local IRB
Coverage analysis and budgeting
Project management
Consenting patients
UCSF (Rheumatology), San Francisco, CA — Assistant Clinical Research Coordinator
June 2015 - June 2016
Creating specimen database
Managing PI oversite meetings
Preparing presentation data
Processing, banking, and shipping specimen
Patient reimbursements
Scheduling patient visits
Managing regulatory items for observational studies
Performing venipuncture
Start-up activities for observational studies
Consenting patients
Center for Clinical Research (Podiatry/Wound Care), San Francisco, CA — Clinical Research Assistant
June 2014 - January 2015
Primary coordinator for patient visits
Performing ECGs
Obtaining vitals
Data entry
Assessing patient reported outcomes
Processing and shipping specimen
Scheduling patient visits
Performing venipuncture on IV drug users
UCLA (Rheumatology), Los Angeles, CA — Assistant Research Coordinator
June 2011 - December 2013
Creation of CRFs
Obtaining vitals
Data entry
Assessing patient reported outcomes
Processing research specimens
Scheduling patient visits
Consenting patients
UCLA (Rheumatology), Los Angeles, CA — Research Assistant
July 2010 - Dec 2013
Banking specimens
Performing point-of-care Westergren Sedimentation Rate tests
Performing flow cytometry
Processing and extracting PBMCs
Extracting DNA
Extracting RNA
EDUCATION
CSUCI, Camarillo, CA — Bachelors of Arts, Psychology
August 2005 - August 2023
College of the Canyons, Santa Clarita, CA — Associate of Arts, Mathematics
August 2002 - August 2005
CERTIFICATES
CCRP — SoCRA
POSTERS
Changes in DNA Methylation Identify Response to Treatment with Methotrexate and TNF Inhibitors Among RA Patients,
Adams, C., Barcellos, L., Criswell, L., Krueger, M, Adams, C., Barcellos, L., Criswell, L., Krueger, M. Changes in DNA Methylation Identify Response to Treatment with Methotrexate and TNF Inhibitors Among RA Patients. Poster presented at the ACR/ARHP Annual Meeting 2018., 2018
PUBLICATIONS
Single-cell RNA-seq analysis reveals cell subsets and gene signatures associated with Rheumatoid Arthritis Disease Activity
Marie Binvigna et. al. (in publication)
Cross-Tissue Trasncriptomic Analysis Leveraging Machine Learning Approaches Identifies New Biomarkers for
Rheumatoid Arthritis
Rychkov, D., Neely, J., Oskotsky, T., Yu, S., Perlmutter, N., Nititham, J., Carvidi, A., Krueger, M., Gross, A., Criswell, L. A., Ashouri, J., Sirota, M, Rychkov, D., Neely, J., Oskotsky, T., Yu, S., Perlmutter, N., Nititham, J., Carvidi, A., Krueger, M., Gross, A., Criswell, L. A., Ashouri, J., Sirota, M. Cross-Tissue Trasncriptomic Analysis Leveraging Machine Learning
Approaches Identifies New Biomarkers, 2021
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