Tracy Kearney
Chicago,IL
Summary
Principal Clinical Research Associate with a track record of managing 30+ clinical trials, enhancing study execution across multiple therapeutic areas. Ensured participant safety and compliance through comprehensive oversight and mentoring of new CRAs. Proven ability to implement effective monitoring strategies and maintain strong relationships with investigational sites.
Overview
11
11
years of professional experience
Work History
PRINCIPAL CRA
THERMO FISHER SCIENTIFIC
Chicago, USA
08.2021 - Current
- Principal Clinical Research Associate on 9 multicenter, phases I-III double-blind, open-label, randomized, observer-blind clinical trials in Hidradenitis Suppurativa, Atopic Dermatitis, Non-Cystic Fibrosis Bronchiectasis, Pulmonary Hypertension, Idiopathic Pulmonary Fibrosis, Pediatric GERD, Infectious Diseases (Covid-19) and Vaccines (Respiratory Syncytial Virus) in adult, adolescent, and pediatric populations.
- Ensured trial compliance with approved protocol, ICH-GCP guidelines, regulations, and SOPs/WPDs to protect participant rights and ensure data reliability.
- Coordinated onsite and remote Pre-Study Assessments, Site Initiations, Clinical Site Monitoring, and Site Close-Outs, achieving 100% or reduced SDV and rSDR.
- Cultivated partnerships with clinical site personnel to improve communication and collaboration.
- Reviews Investigator Site File and ensures subject safety by overseeing accurate and timely AE/SAE reporting and related follow-up.
- Uses different clinical and/or client specific systems for trial management such as EDC, eTMF, CTMS, and Medidata (RAVE).
- Uses IVRS and IRT for IP accountability and management.
- On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD.
SENIOR CRA II
THERMO FISHER SCIENTIFIC
Chicago, USA
03.2020 - 08.2021
- Led 5 Phase I-III double-blind, open-label, randomized clinical trials in musculoskeletal (rheumatoid arthritis) and vaccines (HIV, Covid-19, respiratory syncytial virus) for adult and pediatric subjects.
- Performed all types of on-site and remote Monitoring Visits: SIV, IMV and COV with 100% or reduced SDV and rSDR.
- Used different clinical and/or client specific systems for trial management such as EDC, eTMF.
- Ensured the trial was conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs/WPDs to guarantee participants' rights, well-being, and data reliability.
- Cultivated strong partnerships with investigational sites to enhance study performance and site engagement.
- Supported new CRAs through targeted training and mentoring to ensure adherence to protocols and best practices.
- Created monitoring tools and forms for monitoring team to streamline study data review and improve data integrity.
- As an approved accompanier, conducted authorization visits for new CRAs.
SENIOR CRA II
IQVIA
Chicago, USA
05.2019 - 03.2020
- Managed 7 phases I-III, double-blind, open-label, randomized clinical trials for musculoskeletal (rheumatoid arthritis) and rare diseases (idiopathic pulmonary fibrosis), ensuring adherence to protocols and participant safety.
- Ensured the trial was conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs/WPDs to guarantee participants’ rights, well-being, and data reliability.
- Executed on-site and remote monitoring visits: SIV, IMV, and COV, achieving 100% or reduced source data verification and risk-based monitoring.
- Cultivated collaborative relationships with investigational sites, enhancing communication and cooperation throughout trial processes.
- Used different clinical and/or client specific systems for trial management such as EDC, eTMF.
CLINICAL RESEARCH ASSOCIATE II
PPD
Wilmington, USA
05.2017 - 05.2019
- Conducted 3 phases I-III, double-blind, open-label, randomized clinical trials in rare diseases (hemophilia A/B) and respiratory (COPD) in adult subjects, ensuring adherence to protocol and regulatory standards.
- Executed on-site and remote monitoring visits: SIV, IMV, and COV, achieving 100% or reduced SDV and rSDR to maintain data integrity and compliance.
- Ensured the trial was conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs/WPDs to guarantee participant’s rights, well-being, and data reliability.
- Cultivated collaborative relationships with investigational sites to enhance communication and streamline trial processes.
- Used different clinical and/or client specific systems for trial management such as EDC, eTMF.
REGIONAL CLINICAL RESEARCH ASSOCIATE II
INVENTIV HEALTH CLINICAL
Chicago, USA
06.2016 - 05.2017
- Functioned as Regional CRA I/II for a phase III, double-blind, open label, randomized clinical trial in cardiology/vascular diseases (ASCVD) that included adult subjects.
- Performed all types of on-site and remote Monitoring Visits: SIV, IMV and COV with 100% or reduced SDV and rSDR.
- Ensured compliance with approved protocol, ICH-GCP guidelines, and applicable regulations to uphold participants’ rights, well-being, and data integrity.
- Utilized clinical and client-specific systems for trial management, including EDC and eTMF, to streamline data collection and enhance study oversight.
- Cultivated collaborative relationships with investigational sites to foster effective communication and support study objectives.
REGIONAL CLINICAL RESEARCH ASSOCIATE I
INVENTIV HEALTH CLINICAL
Chicago, USA
05.2015 - 06.2016
- As Regional CRA I/II, worked on 1 phase III, double-blind, open label, randomized Clinical trial in Cardiology/Vascular Diseases (ASCVD) in adult subjects.
- Ensured trial compliance with approved protocol, ICH-GCP guidelines, and applicable regulations to protect participants’ rights, well-being, and ensure data integrity.
- Conducted on-site and remote monitoring visits (SIV, IMV, COV) achieving 100% or reduced SDV and rSDR compliance.
- Cultivated collaborative relationships with investigational sites to facilitate effective study execution.
- Used different clinical and/or client specific systems for trial management such as EDC, eTMF.
Education
Master of Business Administration - General Management
National Louis University
Chicago, IL, USA06-2010
Bachelor of Science - Healthcare Leadership
National Louis University
Chicago, IL, USA06-2006
Skills
- Clinical trial management
- Site monitoring
- Regulatory compliance
- Data management
- Adverse event reporting
- Collaborative relationships
Candidate
Tracy Kearney, Principal Clinical Research Associate, Chicago, IL, Principal Clinical Research Associate with more than 20 years of experience in the clinical research industry, including 10 years as a CRA, 2 years as a Lead Study Coordinator, 3 years as a Project Manager, and 17 years as a Study Coordinator. Experienced in supporting more than 30 clinical trials across various therapeutic areas. Extensive background in Phase I–IV trials, including double-blind, open-label, randomized, and observational studies. Skilled in conducting on-site and remote monitoring visits. Provided comprehensive oversight of all clinical and regulatory aspects for assigned sites from study start-up through close-out., Master of Business Administration (MBA), General Management, National Louis University, Chicago, IL, 06/10, Bachelor of Science (BS), Healthcare Leadership, National Louis University, Chicago, IL, 06/06, PPI Business System Change Champion Certificate, 01/24, PPI Business System Master Mentor Certificate, 01/25, MAST Process Guidance Certification, 01/24, Vaccines Academy Certificate Program, 01/23, Vaccines Academy Certificate Program, 01/20, Thermo Fisher Scientific, Chicago, IL, Principal CRA, 08/21, Present, Principal Clinical Research Associate on 9 multicenter, phases I-III double-blind, open-label, randomized, observer-blind clinical trials., Thermo Fisher Scientific, Chicago, IL, Senior CRA II, 03/20, 08/21, Worked on 5 Phases I-III, double-blind, open-label, randomized Clinical trials., IQVIA, Chicago, IL, Senior CRA II, 05/19, 03/20, Worked on 7 phases I-III, double-blind, open-label, randomized Clinical trials., PPD, Wilmington, NC, Clinical Research Associate II, 05/17, 05/19, Worked on 3 phases I-III, double-blind, open-label, randomized Clinical trials., Inventiv Health Clinical, Chicago, IL, Regional Clinical Research Associate II, 06/16, 05/17, Worked on 1 phase III, double-blind, open label, randomized Clinical trial., Inventiv Health Clinical, Chicago, IL, Regional Clinical Research Associate I, 05/15, 06/16, Worked on 1 phase III, double-blind, open label, randomized Clinical trial., PPI Business System Master Mentor Certification, 08/25, PPI System Change Champion, 12/24, MAST Process Guidance Certification, 01/24, Certified Field Trainer, 04/21, Clinical Foundation Program, 05/17, Clinical Foundation Program, 03/20, Clinical Researcher of the Year Finalist, 01/24, ROCKSTAR AWARD-mRNA 1083-P301, 01/24, Moderna Program Recognition, 01/22, Q4 Spotlight Winner-mRNA 1273-P204, 01/22, SPOT AWARD-mRNA 1273-P204, 01/21, Outstanding work-mRNA 1283-P101, 01/21, English, Fully skilled, Microsoft Office: Word, Excel, Power Point and Access, EDC: Inform and Medidata RAVE, EMR: CRIO, EPIC, Clinical Conductor, Trial Suite, IRT: IWRS, CTMS: Siebel, Veeva, eTMF: Veeva Vault, ePRO, Regulatory: Florence, RealTime, Complion, BOX, Vestigo
Timeline
PRINCIPAL CRA
THERMO FISHER SCIENTIFIC
08.2021 - Current
SENIOR CRA II
THERMO FISHER SCIENTIFIC
03.2020 - 08.2021
SENIOR CRA II
IQVIA
05.2019 - 03.2020
CLINICAL RESEARCH ASSOCIATE II
PPD
05.2017 - 05.2019
REGIONAL CLINICAL RESEARCH ASSOCIATE II
INVENTIV HEALTH CLINICAL
06.2016 - 05.2017
REGIONAL CLINICAL RESEARCH ASSOCIATE I
INVENTIV HEALTH CLINICAL
05.2015 - 06.2016
Master of Business Administration - General Management
National Louis University
Bachelor of Science - Healthcare Leadership
National Louis University