Simi Awotedu
Summary
Dynamic Clinical Research Coordinator with comprehensive background in coordinating clinical research studies. Successfully managed multiple clinical trials from initiation to closeout, ensuring adherence to regulatory guidelines. Skilled in data management and documentation, ensuring compliance with GCP guidelines. Recognized for exceptional organizational skills and a commitment to patient safety, consistently achieving high data integrity throughout clinical trials.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Colfax
10.2024 - Current
- Ensure adherence to clinical research protocols, SOPs, and ICH GCP guidelines.
- Achieve a 50% increase in patient enrollment rates by designing and implementing effective outreach and recruitment strategies.
- Reduce data entry errors by implementing stringent quality control measures at every stage of study lifecycle.
- Monitor patient safety and document adverse events during clinical trials.
- Coordinate clinical trial activities from initiation to close-out, ensuring that essential documents such as informed consent forms, case report forms, and source data are accurately maintained.
- Oversee the management of investigational product (IP) supplies, ensuring storage conditions are maintained at all times to preserve efficacy throughout the trial.
- Prepare and maintain regulatory documentation for clinical trial submissions.
Research Assistant
University of Kentucky
08.2023 - 10.2024
- Collaborated with multidisciplinary teams to develop innovative research methodologies and strategies.
- Conducted experiments using laboratory techniques such as qPCR analysis, electrophoresis, western blotting, and protein, DNA, and RNA extraction to evaluate biomarkers and disease pathways.
- Collected biological samples, including tissues, blood, and urine from experimental models.
- Designed and maintained protocols.
- Performed accurate data analysis, including statistical evaluation and maintained electronic records
- Conducted Literature review and scientific report writing.
Clinical Research Coordinator
Gateway Pharmaceuticals
04.2020 - 06.2023
- Conducted multiple site visits, such as site qualification visit (SQV), site initiation visit (SIV), interim monitoring visit (IMV), and study close-out visit (COV), across trial sites.
- Supported the execution of multiple clinical trials from initiation to close out.
- Achieved high data accuracy and integrity by ensuring timely query resolution and adherence to ALCOA-C data principles, significantly improving overall trial data quality.
- Ensured timely reporting and follow-up of all safety events.
- Assessed site readiness by verifying the availability of essential resources, including qualified staff, site infrastructure, and recruitment capabilities, using a comprehensive site qualification checklist.
- Ensured investigational product (IP) accountability and compliance with all regulatory documentation requirements.
Clinical Research Coordinator
Military Hospital
09.2017 - 03.2020
- Managed daily clinical trial operations, including patient screening, enrollment, and data collection.
- Achieved 40% increase in patient recruitment by enhancing awareness and streamlining the recruitment process, ensuring full compliance with protocol requirements.
- Reported adverse events, concomitant medications, protocol deviations and other unanticipated problems in compliance with regulatory guidelines.
- Prepared and managed essential documentation, including informed consent forms, case report forms (CRFs), contracts, ethics approval, and IRB submissions.
- Scheduled and coordinated patient visits and trial-related appointments.
- Performed regular follow-up on patient progress with investigational product (IP), and maintained effective communication, resulting in over 90% retention rates and minimal dropouts.
- Organized and maintained site files for reporting, ensuring timely submission.
- Ensured proper storage, dispensing, and accountability of the investigational product (IP).
Education
Master of Science - Pharmacology And Nutritional Sciences
University of Kentucky
12-2024
Certificate - Clinical Research Professional Development
The CRA Training Institute
04-2024
Bachelor of Science - Pharmacy
Olabisi Onabanjo University
09-2014
Skills
- Good clinical practices
- Electronic data capture
- Documentation management
- Informed consent
- Adverse event reporting
- Investigational product management
- Patient recruitment
- Phlebotomy
- Time management
- Problem-solving
- Organizational skills
- Data management
Certification
Good Clinical Practice
Phlebotomy
Responsible Conduct of Research
Data Management in Clinical Research
TECHNICAL SYSTEMS
Microsoft Office Suite, Electronic data capture (EDC) including Medidata Rave, oracle,REDCap.
Veeva Vault, Safety Portal, IBM, SPSS, Intralinks, VIPER, and GraphPad.
THERAPEUTIC AREAS
Oncology, Endocrinology, Dermatology, Pediatrics, Neurology, Cardiovascular disease, PHASE 1,II & III Trials.
Timeline
Clinical Research Coordinator
Colfax
10.2024 - Current
Research Assistant
University of Kentucky
08.2023 - 10.2024
Clinical Research Coordinator
Gateway Pharmaceuticals
04.2020 - 06.2023
Clinical Research Coordinator
Military Hospital
09.2017 - 03.2020
Master of Science - Pharmacology And Nutritional Sciences
University of Kentucky
Certificate - Clinical Research Professional Development
The CRA Training Institute
Bachelor of Science - Pharmacy
Olabisi Onabanjo University
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