MARY OLOWOOKERE
Pingree Grove,IL
Overview
12
12
years of professional experience
Work History
Lead Clinical Data Manager
Ampel Biosolutions
01.2023 - 01.2025
- Coordinated efforts with biostatistics teams for insightful analysis reports that informed key decision-making processes.
- Collaborated with cross-functional teams to drive the successful execution of clinical trials.
- Performed thorough review of clinical protocols to identify potential risks or inconsistencies in study design.
- Streamlined clinical trial processes for improved efficiency and reduced study timelines.
- Conducted ongoing assessments of data quality throughout the course of each trial, addressing any issues promptly and effectively.
- Ensured accurate coding of medical terms using MedDRA or WHO-DD dictionaries, facilitating standardized reporting across studies.
Clinical Data Manager/Regulatory Affairs Coordinator
National Institutes of Health
09.2019 - 12.2022
- Contributed to the development and preparation of key study documents, including protocols, case report forms (CRFs), informed consent forms (ICFs), and subject questionnaires
- Ensured study execution aligned with company SOPs, FDA regulations, ICH-GCP guidelines, and other applicable standards
- Verified that CRFs and other study documents were accurately completed and submitted within required timelines
- Reviewed study data for completeness, accuracy, and consistency, resolving queries and protocol deviations in a timely manner
- Ensured adverse events (AEs) were recorded and reported promptly as they occurred
Clinical Research Associate
PPD
05.2016 - 08.2019
- Ensured compliance with FDA regulations, ICH/GCP guidelines, George Clinical SOPs, and sponsor SOPs while monitoring clinical trial activities
- Verified trial data accuracy, completeness, and source document compliance
- Tracked study progress using study tracking tools and ensured timely, high-quality system updates
- 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.
Emergency Room Technician/PCT
Weiss Memorial/ Hospital
01.2013 - 02.2016
- Improved patient satisfaction by providing compassionate and attentive care during high-stress situations.
- Collaborated effectively with multidisciplinary teams to provide comprehensive care for diverse patient populations.
- Assisted healthcare providers in delivering life-saving procedures, contributing to positive patient outcomes.
- Maintained a safe and clean environment through diligent adherence to infection control protocols and standards.
- Recognized potential escalations among distressed patients or family members, effectively utilizing de-escalation techniques to maintain a calm and safe environment.
- Ensured optimal patient comfort by assisting with personal hygiene tasks, mobility support, and wound care.
- Collected basic samples, labeled specimens properly, and transferred to laboratory for testing.
- Demonstrated adaptability in fast-paced environments by managing multiple tasks simultaneously while maintaining high levels of accuracy under pressure.
Education
Bachelor of Science - Nursing
Chamberlain College of Nursing
Chicago, IL01.2016
Associates in Arts -
Truman College
Chicago, IL01.2012
Skills
Empathy
Compassion
HIPAA
Critical Thinking
Time Management
Communication Skills
Patient Education
Team Player
Management Skills
LICENSE
Registered Nurse(RN)- Iowa
Community Involvement
Prince of Peace Parish III Health Department- Illinois
- Health Awareness on Management of Chronic Diseases/Conditions
- Health Fairs- Screening and Assessment
- Mentorship Program
Timeline
Lead Clinical Data Manager
Ampel Biosolutions
01.2023 - 01.2025
Clinical Data Manager/Regulatory Affairs Coordinator
National Institutes of Health
09.2019 - 12.2022
Clinical Research Associate
PPD
05.2016 - 08.2019
Emergency Room Technician/PCT
Weiss Memorial/ Hospital
01.2013 - 02.2016
Associates in Arts -
Truman College
Bachelor of Science - Nursing
Chamberlain College of Nursing
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