Shante Downey
Summary
Experienced Clinical Research Professional with over 20 years of expertise in the clinical research field, including more than 9 years as a Clinical Research Associate (CRA). Proficient in all stages of clinical trials, from protocol development and site initiation to data analysis and close-out. Demonstrated success in managing and monitoring clinical trial sites, ensuring compliance with regulatory standards, and delivering high-quality results. Strong leadership, communication, and problem-solving skills, combined with a deep understanding of GCP, ICH guidelines, and regulatory requirements. Committed to advancing medical research through efficient, ethical, and effective clinical study management.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Clinical Trial Monitor
Winship Cancer Institute
Atlanta
04.2025 - Current
- Monitored delivery of assigned oncology investigational trials, collaborating with Local Study Delivery Teams to meet performance and quality commitments.
- Held full responsibility for the preparation, initiation, monitoring, and closure of oncology trial sites.
- Delivered trials in accordance with ICH-GCP, FDA regulations, institutional SOPs, and applicable local regulations.
- Collaborated with Monitors and Local Study Teams to meet enrollment targets, enhance data quality, and adhere to timelines.
- Conducted site qualification, initiation, interim monitoring, and close-out visits.
- Evaluated regulatory binders, ensured IP accountability, and reviewed pharmacy processes and essential documents for compliance.
- Assessed tumor disease status using RECIST criteria.
- Ensured IRB and Eastern Cooperative Group compliance.
- Acted as primary liaison to the Data Safety Monitoring Committee (DSMC).
Senior CRA
ICON
Atlanta
07.2021 - 04.2024
- Mentored and trained 17 international and national Clinical Research Associates (CRAs) and a Global Site Manager.
- Conducted training sign-offs for CRAs, reviewed and provided feedback on trip and visit reports to ensure compliance with quality standards.
- Authors comprehensive Monitoring Plans tailored to individual studies, aligning with protocol requirements and sponsor expectations.
- Effectively communicates and demonstrates the principles of Investigational Product (IP) accountability, ensuring compliance with regulatory and protocol-specific requirements.
- Represents the organization in client and investigator meetings, presenting study updates, operational plans, and key performance metrics.
- Contributed to development and implementation of process improvements to optimize clinical trial workflows and enhance operational efficiency.
- Maintained compliance of studies with FDA regulations, good clinical practices, IVD directives, and client policies.
- Conducted and documented studies in accordance with study protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements.
- Defined the functional and clinical utility of investigational products during research assessments.
- Obtaining opinions and input regarding investigational products from laboratories or customers who may be considered key opinion leaders.
- Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, or study closeout.
- Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met.
- Supplying data for critical regulatory submissions.
- Validated product performance claims through systematic testing and analysis.
- Enhancing study production by training a team of 17 CRAs and Lead Global Site management Teams for my studies.
Senior Clinical Trial Monitor
Winship Cancer Institute
Atlanta
01.2020 - 07.2021
- Reviewed study processes for compliance with FDA GCP regulations and departmental guidelines, ensuring drug or device accountability and accurate tracking of clinical research pharmacy processes.
- Monitored investigational product (IP) inventory and reconciliation using Vestigo.
- Functioned as a Senior Clinical Trial Monitor and supported all aspects of clinical trials, with a focus on institutional and Eastern Cooperative Group sponsored trials.
- Performed study site initiation and close out visits; and prepared reports for and attending Investigator Meetings and Sponsor meetings.
- Reviewed accuracy, completeness, and timeliness of study records, case report forms, and Investigator Site File (ISF); supervised site activities and served as primary liaison between study teams and Data Safety Monitoring Committee (DSMC).
- Documented monitoring activities using standardized reporting formats, effectively communicating findings to relevant stakeholders.
- Conducted site qualification, site initiation and close out visits and ensuring regulatory, ICH-GCP protocol compliance.
- Performed monitoring tasks that verified adherence to the study protocol and regulations set by the Institutional Review Board.
Clinical Research Associate
Inova Clinical Trials and Research Center
Fayetteville
01.2016 - 01.2020
- Managed regulatory authority applications and approvals as a Clinical Research Associate; ensured documentation accuracy, quality, and compliance.
- Performed data verification, generated queries, and oversaw resolutions through remote or site monitoring visits (phase I, II, and III) to uphold quality and protocol compliance at investigative sites.
- Provided operational and administrative support in managing patient involvement in research protocols to maintain protocol compliance.
- Provided supervision to site staff and team members; and facilitated project team meetings.
- Oversaw inventory levels and replenished consumable laboratory supplies to maintain operational efficiency.
Clinical Laboratory Scientist
Kaiser Permanente
Jonesboro
10.2014 - 01.2020
- Performed requested laboratory tests and special analysis, such as proficiency testing, correlation studies or other, according to established laboratory and Medical Office policies and procedures.
- Performed calibration and calibration verification. Operated and maintained equipment, conducting routine safety checks and preventive maintenance on instruments according to procedures and manufacturer's recommendations.
- Utilized quality control procedures according to established procedures and review regulatory documents and ensure compliance.
- Communicated with reference lab to confirm results and specimen disposition, ordered supplies, and resolved pending lists per policy.
- Recognized trends and unexpected patterns, taking appropriate actions to address issues promptly.
- Monitored medical oncology patients, promptly responding to changes in health and well-being.
- Participated in orientation and training of new employees, and in state/internal inspections, prepared to answer questions, or produce documents.
Clinical Research Coordinator
Inova Clinical Trials and Research Center
Fayetteville
01.2014 - 10.2016
- Coordinated clinical trials by adhering to Good Clinical Practices and study protocols, interviewing and recruiting patients, and maintaining accurate patient files.
- Completed case report forms per FDA guidelines, ensuring thorough review against patient's medical records for completeness and accuracy.
- Maintained regulatory and subject binders, report adverse events.
- Collected, processed, and shipped blood and urine specimens during scheduled patient visits, ensuring compliance with trial protocols.
Education
Undergraduate - Clinical Laboratory Science
University Of Louisiana at Monroe
Monroe, Louisiana, United States of America05.2004
Skills
- Clinical trial monitoring
- Regulatory compliance
- Protocol adherence
- Data quality assurance
- Investigational product management
- Site selection
- Data analysis
- Process improvement
- Medical terminology
- Attention to detail
- Team collaboration
- Effective communication
- Problem solving
- Mentorship and training
- Incident reporting
Drug Type Experience
Drug Type: Therapeutic Area/Subject Population
- Biologic (other not listed): Cardiovascular, Psychiatry/ Adult, Pediatric
- Diagnostic (Imaging): Oncology (Solid and Liquid Tumors)/ Oncology Subjects
- Drug-Device Combination: Oncology (Solid Tumors)/ Adult
- Radiopharmaceutical, Oncology (Solid Tumors): Adult, Female Only, Male Only
Certification
Medical Laboratory Scientist, American Medical Technologist, United States of America, 05/01/04
Environment Experience
- Oncology (Solid Tumors), Adult
- Doctor's Office, Cardiovascular, Oncology (Solid Tumors), Psychiatry, Adult, Female Only, Male Only, Oncology Subjects, Pediatric
System Experience
- Clinical Trial Management Systems: Medidata CTMS, OnCore
- EDC: InForm, ISS Sponsor EDC, Medidata RAVE, Veeva Vault EDC, Medrio, Advarra, RedCap
- Laboratory System: Labware LIMS
- Regulatory: ISS Sponsor Regulatory system, WCG (Wirb), Insight
- TMF: Veeva Vault ETMF
Degree
BS
Personal Information
Title: Senior CRA
Languages
English
Geographic Experience
Country or Region: Therapeutic Area/ Role
- China: Oncology (Solid Tumors)/ Senior CRA
- Singapore: Oncology (Solid Tumors)/ Senior CRA
- United Kingdom of Great Britain and Northern Ireland: Oncology (Solid Tumors)/ Senior CRA
- United States of America: Cardiovascular, Oncology (Solid Tumors), Psychiatry/ CRA
Protocol Therapeutic Experience
Therapeutic Area: Indication Group/Primary Indication/Role/Duration/Phase/Subject Population
- Cardiovascular: Pulmonary Hypertension/CRA/3 yrs, 11 mos/ II/III/Adult
- Oncology (Solid Tumors): Breast/CRA/ 1 yr, 4 mos/II/III/Female Only
- Oncology (Solid Tumors): Gi Tumors/Senior CRA/6 yrs, 7 mos/ IV/Adult
- Oncology (Solid Tumors): Gi Tumors/Senior CRA/6 yrs, 8 mos/ III/Adult
- Oncology (Solid Tumors): Gi Tumors/CRA/ 6 yr, 4 mos/II/III, Adult
- Oncology (Solid Tumors): Gu Tumors/ CRA/6 yr, 4 mos/ II/III/Male Only
- Oncology (Solid Tumors): Head And Neck Tumors/CRA/6 yr, 4 mos/II/III/ Oncology Subjects
- Oncology (Solid Tumors): Lung Cancer/CRA/6 yr, 4 mos/ II/III, Adult
- Psychiatry: Neurotic Disorder/CRA/3 yrs, 11 mos/I/II/Pediatric
- Psychiatry: Neurotic Disorder/CRA/3 yr, 11 mos/ I/II,/Pediatric
Timeline
Senior Clinical Trial Monitor
Winship Cancer Institute
04.2025 - Current
Senior CRA
ICON
07.2021 - 04.2024
Senior Clinical Trial Monitor
Winship Cancer Institute
01.2020 - 07.2021
Clinical Research Associate
Inova Clinical Trials and Research Center
01.2016 - 01.2020
Clinical Laboratory Scientist
Kaiser Permanente
10.2014 - 01.2020
Clinical Research Coordinator
Inova Clinical Trials and Research Center
01.2014 - 10.2016
Undergraduate - Clinical Laboratory Science
University Of Louisiana at Monroe