Paige Oluwasanmi
Houston,TX
Summary
I aim to utilize my extensive experience while seeking new challenges. I am a proficient clinical research professional with over eight years of experience, specializing in Central Nervous Systems, Infectious Diseases, and cardiovascular clinical trials.
Overview
14
14
years of professional experience
Work History
Senior Clinical Research Associate II
Syneos Health
08.2019 - Current
- Maintain effective communication within the team and with site staff
- Ensure compliance with local regulations, CFR/ICH, GCP guidelines, and SOPs
- Manage site performance and compliance with protocol requirements
- Perform source data verification and Case Report Form submissions
- Monitor key study performance indicators and resolve site-specific issues.
- Created and assessed strategies to streamline trial oversight.
- Oversee clinical monitoring activities, including on-site and remote monitoring
- Track study progress, site activations, patient enrollments, and monitoring visits
- Ensure the accuracy and completeness of the Trial Master File (TMF)
- Stay updated on GCP, FDA, and relevant regulations
- Efficiently manage cross-functional projects.
Senior Clinical Research Associate I
Syneos Health
09.2017 - 08.2019
- Demonstrate in-depth knowledge of project-specific protocols
- Conduct on-site monitoring as per project timelines
- Complete site monitoring reports, letters, and regulatory tasks
- Ensure resolution of site issues and action items
- Maintain site visit records and communication logs.
Clinical Research Associate II
Syneos Health
08.2015 - 09.2017
- Conduct Site Initiation visits and train site personnel
- Monitor study sites to ensure compliance with protocols and regulations
- Manage multiple protocols across therapeutic areas
- Ensure data quality and safety of study subjects
- Facilitate audit processes and mentor colleagues
- Prepare and submit accurate reports.
Clinical Research Associate
Quintiles
06.2013 - 08.2015
- Perform site monitoring visits for various study phases
- Assist sites in resolving deficiencies and follow-up
- Contribute to protocol development and review
- Mentor junior clinical team members
- Build effective relationships with clinical sites
- Attend meetings and conferences.
Clinical Research Coordinator
Rutgers University
02.2011 - 06.2013
- Participate in study visits and subject recruitment
- Coordinate clinical tests and data collection
- Track clinical data and study expenditures
- Maintain confidentiality and ensure compliance with guidelines
- Assist regulatory affairs and manage files.
Education
Bachelor of Science - Finance, Statistics
Rutgers University, Rutgers Business School
Skills
- Regulatory compliance
- Data management
- Clinical monitoring
- Source data verification
- Trial Master File management
- Project management
- Site management
- Risk assessment
- Patient enrollment
- Effective communication
- Problem solving
- Attention to detail
- Training site personnel
- Audit facilitation
- ICH-gCP guidelines
- Site monitoring expertise
- Teamwork
- Monitoring visits
Accomplishments
- Central Nervous Systems (CNS): Including PTSD, BPD, ADHD, and ADD
- Rare Diseases: Covering Rare Genetic Disorders and Xerostomia (Dry Mouth)
- Medical Devices: Involving Catheters, Inhalers, and Heart Valves
- Ophthalmology: Focusing on Glaucoma and Diabetic Macular Edema
- Infectious Diseases: Encompassing Vaccines, HIV, and Hepatitis
- Dermatology: Addressing Acne and Psoriasis
- Cardiology: Dealing with Heart Attacks and Strokes
Timeline
Senior Clinical Research Associate II
Syneos Health
08.2019 - Current
Senior Clinical Research Associate I
Syneos Health
09.2017 - 08.2019
Clinical Research Associate II
Syneos Health
08.2015 - 09.2017
Clinical Research Associate
Quintiles
06.2013 - 08.2015
Clinical Research Coordinator
Rutgers University
02.2011 - 06.2013
Bachelor of Science - Finance, Statistics
Rutgers University, Rutgers Business School
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