ASHLEY CREQUE
Charlotte,NC
Summary
Experienced Senior-level clinical trial operations professional with 10+ years of clinical research experience. Broad background in clinical trial management from data management, query resolution, statistical analysis, subject recruitment, site feasibility, startup, regulatory, and trial monitoring. Possesses masters-level public health degree specializing in Epidemiology. Served as a CRA for 8+ years specializing in oncology, cardiology, rheumatology, infectious disease, respiratory, and vaccines.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate, Biotech - Oncology
Parexel
06.2023 - Current
- Conducts initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Oversees conduct of trial at designated sites to ensure rights and well-being of subjects are protected
- Ensures quality and integrity of the data, and ensures the sites are in compliance with protocol, study requirements, GCP and applicable regulatory requirements
- Perform site qualification, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations
- Ensure timely and accurate access and updates of applicable trial management systems and trial master file documents
- Assesses & manages test article/study supply including supply, accountability and destruction/return status
- Reviews site recruitment plans and takes action to drive recruitment
- Reviews and follows up regarding site payments
- Perform in-house activities related to management of study sites, including payments, regular site phone contacts, remote data review
- Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Works independently and manages multiple priorities to achieve project timelines
Senior Clinical Site Manager, Early Phase - Oncology
Parexel
06.2019 - 03.2021
- Performed site qualification, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- Developed protocols and operational procedures for clinical trials, ensuring adherence to regulatory guidelines.
- Assisted with creation of consent forms, monitoring plans, case report forms, study manuals, training material, monitoring plans and other clinical documents
- Oversaw investigative site compliance, conducting pre-study, initiation, interim, and closeout visits, as well as site and study management
- Collaborated with clinical sites and research departments to ensure adequate clinical and non-clinical supplies, maintaining open communication for trial-related activities
- Ensured quality and integrity of the data, and ensures the sites are in compliance with protocol, study requirements, GCP and applicable regulatory requirements
- Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Ensured timely and accurate access and updates of applicable trial management systems and trial master file documents
- Assessed & manages test article/study supply including supply, accountability and destruction/return status
- Reviewed site recruitment plans and took actions to drive recruitment
- Reviewed and follows up regarding site payments
- Performed in-house activities related to management of study sites, including (but not limited to) payments, regular site phone contacts, remote data review
- Actively participated in Investigator and other external or internal meetings, audits & regulatory inspections as required
- Worked independently and managed multiple priorities to achieve project timelines
- Monitored clinical progress and serve as clinical project contact with sponsor/client.
- Developed clinical operations plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures.
- Trained and provided guidance to CRAs/Clinical team and advising on critical specific study issues
- Collaborated with other functional groups to support milestone achievement and manage study issues and obstacles
- Ensured all appropriate recruitment strategies are in place to maximize recruitment opportunities
Senior Clinical Research Associate
ICON (Formerly PRA Health Sciences)
06.2016 - 06.2019
- Performedthe full range of clinical research site management responsibilities and ensure that study is conducted according to the protocol, ICH GCPs, IRB provisions, regulatory requirements and sponsor SOPs
- Performed investigator site identification, evaluation and selection, including pre-study site visits and feasibility studies
- Set up new research sites, guide sites on submission of regulatory documents and perform site initiation
- Scheduled monitor visits to perform source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight and regulatory file review and oversight
- Documented site progress in monitor reports and relay issues to study team
- Troubleshooted and problem solved at sites to achieve turnaround results
- Trained new research personnel, including Study Coordinators, Investigators, and site pharmacists
- Performed site closure visits and tasks including IP reconciliation and disposition, review of accuracy and completeness of study files, and retrieval of all outstanding documents
- Gathered and maintain documentation for sponsor trial master file
- Monitored drug inventory, dispensing, compliance and return
- Tracked and reported site enrollment, recruitment progress, deviations, and adverse events
- Ensured regulatory documents are complete and in compliance with federal and internal guidelines
- Assured Investigator and site adherence to timelines and GCPs
- Prepared and submit trip reports, expense reports, and timesheets
- Assisted in the development of study source worksheets, CRFs, and tracking documents.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
Clinical Research Associate II,
Novella Clinical Resourcing
11.2013 - 06.2016
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance
- Performed study assessment, pre-study activity, initiation, interim monitoring, transfer and close out visits
- Obtained and reviewed regulatory documentation for successful implementation, monitoring, and evaluation of clinical trial
- Performed study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF
- Conducted periodic site file audits to ensure compliance with GCPs and Sponsor SOPs and guidance
- Assured adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on and off-site monitoring visits
- Performed validation of source documentation
- Documented accountability, stability and storage conditions of clinical trial materials
- Reviewed the quality and integrity of the patient clinical data through in house review of eCRF data and on-site source verification
- Served as primary contact between sponsor and investigator
- Assisted with final data review and query resolution through database lock
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion
- Maintained compliance with protocols covering patient care and clinical trial operatio
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Liaised with clinical investigators to identify, assess and resolve site performance, quality and compliance issues.
Clinical Research Associate I
Ockham Development Group, Inc.
09.2011 - 11.2013
- Performed the full range of clinical research site management responsibilities and ensure that study is conducted according to the protocol, ICH GCPs, IRB provisions, regulatory requirements and sponsor SOPs
- Performed investigator site identification, evaluation and selection, including pre-study site visits and feasibility studies
- Set up new research sites, guide sites on submission of regulatory documents and perform site initiation
- Scheduled monitor visits to perform source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight and regulatory file review and oversight
- Documented site progress in monitor reports and relay issues to study team
- Troubleshooting and problem solving at sites to achieve turnaround results
- Performed training of new research personnel, including Study Coordinators, Investigators, and site pharmacists
- Site closure visits and tasks including IP reconciliation and disposition, review of accuracy and completeness of study files, and retrieval of all outstanding documents
- Gathered and maintained documentation for sponsor trial master file
- Monitored drug inventory, dispensing, compliance and return
- Tracked and reported site enrollment, recruitment progress, deviations, and adverse events
- Ensured regulatory documents are complete and in compliance with federal and internal guidelines
- Assured Investigator and site adherence to timelines and GCPs
- Prepared and submit trip reports, expense reports, and timesheets
- Assisted in the development of study source worksheets, CRFs, and tracking documents.
Study Coordinator/Data Research Manager
North Shore LIJ Health System
06.2010 - 09.2011
- Monitored Phase I-IV clinical trials in oncology
- Supported study start-up activities and perform regulatory duties for site approval
- Collected subject screening information, register and randomize study subjects to study
- Obtained patient health records, transcribe subject data into eCRF, and resolve data queries
- Maintained strict adherence to ICH GCP, regulatory and sponsor guidelines
- Reported adverse events, deviations and/or violations to ADEERS, sponsor and or institution's IRB when appropriate
- Create site Note to File and assist with implementation of corrective action plans, when appropriate
- Completed study regulatory submissions and continuing review reports
- Validated subject visit information for subject reimbursement of study-related procedures
- Processed, analyzed, and/or packaged biological specimens for shipment to central lab
- Worked with principal investigators, CRO and sponsors to facilitate daily trial activities in compliance with research protocols
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Collected data and followed research protocols, operations manuals, and case report form requirements
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
Education
M.P.H., Epidemiology -
Mailman School of Public Health, COLUMBIA UNIVERSITY
05.2013
B.S., Animal Science -
College of Agriculture and Life Sciences, CORNELL UNIVERSITY
05.2010
Skills
- ICH Good Clinical Practice
- Coordinating Site Operations
- Clinical Site Management
- Electronic Data Capture & Query Resolution
- Clinical Trial Management System
- Clinical Monitoring
Certification
- HIPAA
- CITI Human Subjects
- Certification in Healthcare Leadership, CORNELL UNIVERSITY, February 2013
Therapeutic Area Expertise
- Lung Cancer, II-III, 2 yrs, USA, CRA, SC
- Breast Cancer, I, 2 yrs, USA, Europe, CRA
- MDS, I-III, 3 yrs, USA, CRA, SC
- Uterine Cancer, I-III, 4 yrs, USA, CRA, SC
- AML, II, 3 yrs, USA, CRA, SC
- CLL, I-II, 3 yrs, USA, Europe, CR
- Allergic Asthma, II, 3 yrs, USA, CRA
- Vaccines- MMR (Pediatric), II, 2 yrs, USA, CRA
- Influenza, II - III, 4 yrs, USA, Canada, Eastern Europe, CRA
- COPD, II-III, 2 yrs, USA, Europe, CRA
- Diabetes Mellitus Type II, I-II, 2.5 yrs, USA, CRA
- Coronary Artery Disease, I, 2 yrs, USA, CRA
- Myocardial Infarction, II & IV, 2 yrs, USA, CRA
- Arrhythmia, II, 2 yrs, USA, CRA
- Pulmonary Hypertension, I-II, 4 yrs, USA, CRA
- Stroke, I, 1, USA, CRA
- Autoimmune/Lupus, III-IV, 2 yrs, USA, CRA
- Fibromyalgia, II, 2 yrs, USA, Europe, CRA
- Osteoarthritis, IV, 2 yrs, USA, CRA
- Lyme Disease, I, 1 yr, USA, Europe, CRA
Summary Of Experience
Experienced Clinical Site Manager with 10+ years of clinical research experience. Broad background in clinical trial management from data collection, data management/analysis, patient research education and recruitment, startup/regulatory, and trial monitoring. Possesses masters-level public health degree specializing in Epidemiology. Served as a CRA for 8 years specializing in oncology, cardiology, rheumatology, infectious disease, respiratory, and vaccines.
Publications
Disparities in uterine cancer survival in a Brooklyn cohort of black women, Future Oncology, 6, 2, 319-327, 2010
Affiliations
Delta Sigma Theta Sorority, Inc
Timeline
Senior Clinical Research Associate, Biotech - Oncology
Parexel
06.2023 - Current
Senior Clinical Site Manager, Early Phase - Oncology
Parexel
06.2019 - 03.2021
Senior Clinical Research Associate
ICON (Formerly PRA Health Sciences)
06.2016 - 06.2019
Clinical Research Associate II,
Novella Clinical Resourcing
11.2013 - 06.2016
Clinical Research Associate I
Ockham Development Group, Inc.
09.2011 - 11.2013
Study Coordinator/Data Research Manager
North Shore LIJ Health System
06.2010 - 09.2011
M.P.H., Epidemiology -
Mailman School of Public Health, COLUMBIA UNIVERSITY
B.S., Animal Science -
College of Agriculture and Life Sciences, CORNELL UNIVERSITY