An experienced medical doctor with over 5 years experience, specializing in all aspects of patient care, safety practices and clinical research including protocol review, subject enrollments, CTMS, EDMS, TMF, regulatory compliance, and SAE reporting. A proven track record of collaborating with multidisciplinary teams to execute complex clinical and research initiatives.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Associate
Richmond Gastroenterology Associates
06.2023 - Current
Deliver research support for a series of clinical trials, including IRB submissions, patient recruitment, and development of study protocols.
Utilize clinical trial management systems (CTMS) to coordinate project management functions of clinical trials, including patient tracking and study deviations.
Coordinate and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Collaborate with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
Participate in initiation visits and investigator meetings, implementing trials following study timelines and budgets
Oversee Serious Adverse Event (SAE) reporting activities, including coordinating with Principal Investigator to ensure transparency and accurate reporting of adverse events
Follow clinical research protocols and conduct study visits in compliance with ICH/GCP and FDA regulations.
Develop and implement strategies to streamline communication between internal and external stakeholders.
Investigate escalated liaison issues and implemented appropriate tactics for swift resolution.
Collect, evaluate, and model collected data.
Graduate Research Assistant (Part-Time)
State University of New York at Oswego
08.2022 - 04.2023
Assisted faculty members with data collection for potential academic publications
Analyzed acquired information and presented to professors
Administered coursework, graded assignments, and provided constructive feedback
Gathered, reviewed, and summarized literature from scientific journals such as SciFinder and PubMed and produced graphs and other scientific calculations using MS Excel.
Clinical Trial Sub-Investigator
Ghana Health Service-Regional Division
10.2019 - 11.2021
Collaborated with federal agencies on clinical trial investigations.
Collaborated with regional research team to develop research proposals and prepare grant applications.
Worked local pharmaceutical companies on drug development and patient safety evaluations.
Led research projects to investigate therapies for malaria treatment and other rare tropical diseases through the National Research Program.
Partnered with National Research Institute on COVID-19 studies.
Medical Doctor
Ghana Health Service-Sefwi Wiawso Reg. Hospital
07.2019 - 11.2021
Educated patients and their families on medical topics and health maintenance
Diagnosed and treated wide variety of medical conditions in patients of all ages.
Maintained confidentiality of patient information according to federal guidelines and regulations.
Teamed with other physicians, specialists, and health care providers to provide well-rounded care for complex cases.
Provided emergent medical care and treatment for life-threatening injuries and illnesses.
Ordered and executed various tests, analyses, and diagnostic images to provide information on patient condition.
Educated patients and families on benefits of healthy diet and adequate exercise
Education
Master Of Science-Biomed And Health Informatics - Health Project Management
State University of New York At Oswego
Oswego, NY
Doctor of Medicine - Medicine
Kharkiv National Medical University
Kharkiv, Ukraine
Skills
Program Leadership/Management
Operational planning and Policy Development
GCP/ICH
Staff Development and Hiring Practices
Site Safety
Clinical Research
CTMS and EDC systems
ICH Guidelines
Representative experience
Collaborative relationships
Reporting Standards
Facility Management
Negotiations
Certification
ACRP-CP
GCP
IATA
Human Subject Research-CITI
Accomplishments
Spearheaded the establishment of Richmond Gastroenterology Associates' clinical research division, which now has four satellite locations in the Richmond, Virginia, area.
Liaised with various accreditation agencies to ensure all regulatory requirements were met and investigator certifications were active prior to activation of our first study.
Successfully integrated the use Clinical-Trial Monitoring Systems by partnering with Real-Times CTMS to ensure efficiency in various documentations and program organizations.
Contracts involving key regional and national stakeholders and CROS were reviewed and signed, resulting in the activation of eight new clinical trial studies in our first year.
Timeline
Lead Clinical Research Associate
Richmond Gastroenterology Associates
06.2023 - Current
Graduate Research Assistant (Part-Time)
State University of New York at Oswego
08.2022 - 04.2023
Clinical Trial Sub-Investigator
Ghana Health Service-Regional Division
10.2019 - 11.2021
Medical Doctor
Ghana Health Service-Sefwi Wiawso Reg. Hospital
07.2019 - 11.2021
Master Of Science-Biomed And Health Informatics - Health Project Management
State University of New York At Oswego
Doctor of Medicine - Medicine
Kharkiv National Medical University
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