CAROLYN IDUH
Royse City
Summary
Clinical research leader with 10+ years of experience delivering global Phase I–III clinical trials across multiple therapeutic areas including oncology, neurology, cardiovascular disease, endocrinology, and respiratory disorders. Proven ability to lead complex multi-site trials from study start-up through close-out, ensuring regulatory compliance, operational excellence, and delivery of high-quality clinical data. Currently serving as Lead Clinical Research Associate at AstraZeneca providing oversight of site performance, operational execution, and regulatory compliance for global clinical studies. Recognized for strong leadership in site management, cross-functional collaboration, operational risk mitigation, and inspection readiness. Experienced in supporting country-level study delivery, improving site performance, mentoring CRAs, and maintaining strong partnerships with investigators and study teams.
Overview
16
16
years of professional experience
Work History
Lead Clinical Researcher Associate
AstraZeneca
Dallas
07.2022 - Current
- Provide operational oversight for global Phase II–III clinical trials across multiple investigative sites, ensuring study delivery in accordance with sponsor procedures, regulatory requirements, and ICH-GCP standards.
- Lead monitoring and operational oversight of clinical trial sites from site feasibility through study close-out, ensuring compliance with protocol and study timelines.
- Serve as the primary liaison between investigators, site personnel, and global study teams, ensuring clear communication and timely resolution of study issues.
- Conduct and oversee Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV) for multi-center clinical trials.
- Identify operational risks and implement mitigation strategies to ensure timely delivery of study milestones and enrollment targets.
- Provide leadership and guidance to investigators, study coordinators, and site personnel to improve site performance and protocol adherence.
- Ensure inspection-ready documentation, including regulatory binders, essential documents, and electronic Trial Master File (eTMF) records.
- Collaborate closely with Global Study Managers, Medical Monitors, Regulatory Affairs, and Data Management teams to support successful study execution.
- Contribute to country-level study oversight by supporting Local Study Associate Director activities including operational planning and risk management.
- Mentor and support junior CRAs to ensure consistent monitoring quality and adherence to monitoring plans.
- Support patient recruitment strategies and site engagement initiatives to improve study enrollment.
- Currently performing LSAD stretch responsibilities, supporting country-level study management activities including study oversight, risk identification, and operational coordination.
Clinical Trial Lead
Parexel
Dallas
12.2018 - 11.2019
- Led operational delivery of clinical trials across multiple investigational sites while ensuring compliance with sponsor requirements, regulatory standards, and clinical trial protocols.
- Managed monitoring activities including site qualification, initiation, interim monitoring, and close-out visits.
- Coordinated cross-functional study teams including clinical operations, regulatory affairs, investigators, and data management.
- Responsible for management of the full scope of clinical operations activities and coordinating cross-functional efforts in the administration and progress of clinical trial(s) to achieve trial objectives and corporate goals for assigned study sites.
- Monitored site performance and recruitment metrics, implementing strategies to address operational challenges.
- Managed study documentation, including regulatory submissions, IRB communication, and essential document management.
- Ensured high-quality clinical data through source data verification and EDC oversight.
- Contributed to study start-up planning, investigator training, and protocol implementation.
Clinical Research Associate I/II
PPD
Dallas
06.2014 - 11.2018
- Supported global clinical trials by providing operational oversight of investigational sites and ensuring compliance with study protocols and regulatory requirements.
- Conducted site feasibility assessments, Site Qualification Visits (SQV), SIVs, monitoring visits, and close-out visits.
- Collaborated with Project Manager to set targets for clinical monitoring staff, and ensure recording of trials in compliance with project goals to fill in for absent CTL.
- Collaborated with project managers and global teams to ensure timely study execution and milestone achievement.
- Created and oversaw trial budget.
- Trained investigators and site staff on protocol procedures and regulatory requirements.
- Maintained regulatory documentation and ensured Trial Master File completeness and inspection readiness.
- Supported patient recruitment and retention initiatives.
Clinical Research Coordinator
Global Medical Research
03.2010 - 04.2014
- Supported clinical trial operations and patient coordination activities for multiple research studies.
- Assisted in defined aspects of clinical trials to ensure trials are completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
- Coordinated patient recruitment, screening, informed consent, and study visits.
- Maintained regulatory documentation and IRB submissions.
- Maintained study timelines and assisted with projection and management of both clinical and non-clinical supplies.
- Ensured compliance with study protocols and Good Clinical Practice standards.
- Maintained study documentation within the Trial Master File.
Education
BACHELOR OF SCIENCE - Psychology, Neuroscience
Southern Methodist University
Dallas, TXAssociate - Psychology
Queen Mary University of London
LondonAssociate of Applied Science - Biological and social sciences
El Centro College
Dallas, TexasMaster of Science - Applied Cognition and Neuroscience Intraoperative
University of Texas Dallas
Doctor of Science - Clinical Neuropsychology
University of north Texas
Skills
- Clinical Trial Leadership
- Local Study Team Coordination
- Global Clinical Trial Operations
- Site Selection & Feasibility
- Operational Risk Identification & Mitigation
- Monitoring Strategy Implementation
- ICH-GCP & Regulatory Compliance
- Inspection Readiness & eTMF Oversight
- Patient Recruitment Strategy
- Cross-Functional Collaboration
- Vendor & Stakeholder Management
- Clinical Study Planning & Execution
- Medidata Rave
- Inform EDC
- IBM eClinical
- Medrio
- Impact Harmony CTMS
- Veeva Vault eTMF
- Endpoint IVRS/IWRS
- MS Project
- Excel
- PowerPoint
- Word
Awards
- Phi Theta Kappa Honors Award
- Erin Tierney Kramp Encouragement Scholar
- Southern Methodist Transfer Scholar
- IFSA- BUTLER First Generation Scholar - London – Queen Mary University
- Southern Methodist University Study Scholar 2018
- Southern Methodist University Merit Support Award
- Best Scientific Author and Publisher - Departmental Awards (Emerging Neuroscientist) - 2024
Timeline
Lead Clinical Researcher Associate
AstraZeneca
07.2022 - Current
Clinical Trial Lead
Parexel
12.2018 - 11.2019
Clinical Research Associate I/II
PPD
06.2014 - 11.2018
Clinical Research Coordinator
Global Medical Research
03.2010 - 04.2014
BACHELOR OF SCIENCE - Psychology, Neuroscience
Southern Methodist University
Associate - Psychology
Queen Mary University of London
Associate of Applied Science - Biological and social sciences
El Centro College
Master of Science - Applied Cognition and Neuroscience Intraoperative
University of Texas Dallas
Doctor of Science - Clinical Neuropsychology
University of north Texas