Izizi OKPARA
Atlanta
Summary
Clinical research professional with solid experience in managing and monitoring clinical trials. Strong focus on team collaboration and achieving results, adaptable to changing needs. Skilled in data analysis, protocol adherence, regulatory compliance, and patient interaction. Reliable and prepared to make impactful contribution to clinical research initiatives.
Overview
6
6
years of professional experience
Work History
Clinical Research Associate
NSABP Foundation
Pittsburgh, PA
09.2024 - Current
- Conducted site visits to ensure compliance with clinical protocols and regulatory requirements.
- Assisted in the preparation and submission of regulatory documents for clinical trials.
- Monitored patient recruitment and retention efforts to optimize trial timelines.
- Collaborated with cross-functional teams to support study execution and data collection processes.
- Facilitated communication between investigators, sponsors, and regulatory bodies throughout trial phases.
- Maintained comprehensive records of site activities, ensuring readiness for audits and inspections.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Clinical Research Associate
NX Development Corp.
Lexington, KY
01.2022 - 09.2024
- Conducted thorough reviews of clinical data to ensure adherence to established study protocols and maintain integrity.
- Developed instructional materials for site personnel, focusing on effective study procedure execution and accurate documentation practices.
- Oversaw data quality enhancement by meticulously monitoring study progress and ensuring precise data collection.
- Oversaw human subject safety and directed consent processes to maintain compliance with regulatory standards.
- Coordinated with clinical project leader to identify and troubleshoot study-related concerns.
- Maintained in-depth knowledge of regulatory requirements to uphold compliance during clinical trial processes.
- Assessed participant eligibility and consent forms to facilitate accurate and meaningful research outcomes.
- Ensured accuracy and integrity of research study regulatory documents by systematically organizing and maintaining site binder.
- Engaged with clinical investigator to enhance site performance by addressing quality and compliance challenges.
- Enhanced patient enrollment through strategic development and implementation of targeted recruitment initiatives.
- Monitored industry trends through active participation in conferences and professional development events.
- Facilitated communication between clinical investigators and site staff to uphold ethical research practices aligned with study objectives.
- Streamlined collection and organization of clinical trial documentation to ensure compliance with site approval standards.
- Conducted meetings with sponsor representatives to discuss clinical study developments.
- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
Clinical Research Coordinator
NYU Langone
New York, NY
10.2019 - 12.2021
- Coordinated multi-site clinical trials, ensuring compliance with regulatory standards and protocols.
- Collaborated with investigators to design study protocols and informed consent documents.
- Managed recruitment strategies, enhancing participant enrollment through community outreach initiatives.
- Oversaw data collection and verification processes, maintaining accuracy in trial results documentation.
- Monitored study progress, identifying potential issues and implementing corrective actions promptly.
- Established relationships with external stakeholders, fostering collaboration between research teams and sponsors.
Education
Bachelor of Science -
Ambrose Ali University
Skills
- Site management
- Pharmacovigilance
- Detailed documentation
- Electronic data capture
- Coordinating site operations
- Project monitoring
- Adverse event reporting
- Site monitoring
- Clinical trial management
- Clinical documentation
- Source document verification
- Report writing
Affiliations
SOCRA
Timeline
Clinical Research Associate
NSABP Foundation
09.2024 - Current
Clinical Research Associate
NX Development Corp.
01.2022 - 09.2024
Clinical Research Coordinator
NYU Langone
10.2019 - 12.2021
Bachelor of Science -
Ambrose Ali University