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Clinical Research Trials

Location:
Joppatowne, MD, 21085
Salary:
130000
Posted:
January 21, 2024

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Resume:

SUMMARY

A dedicated professional with over * years of experience in clinical trials, offering expertise in planning, organizing, and executing phase I-IV clinical trials. Proven track record of success in clinical trial monitoring and data management, with specific experience in Alzheimer’s, COVID, Hematology-Oncology, Rare diseases, and Psychiatry. Hold a medical degree with a Postgraduate certificate in clinical research.

EXPERIENCE

Clinical research Associate

Alzheimer's Therapeutics Research Institute June 2021 - Present, San Diego, CA

Managed clinical trial for FDA-approved medication used in Alzheimer's treatment.

Conducted regular, independent visits to assigned study sites to review case report forms (CRFs) and ensure data accuracy.

Assessed data accuracy, quality, and completeness of initial source data review, and close-out visits in a timely manner. Achieved 99% accuracy on review of CRFs and source documents.

Increased accuracy of data collection through implementing a monitoring system which increased satisfaction ratings from sponsors by 10%.

Reviewed and evaluated clinical interviews and neuropsychological tests, ensuring standardized ratings and scores.

Acted as the main point of contact for study sites, addressing inquiries related to study conduct and medical safety in collaboration with the medical safety team.

Clinical Research Coordinator 2

Stanford University September 2020 - June 2021, Palo Alto, CA

Supervised and managed investigator-initiated multisite COVID trials, ensuring smooth operations and adherence to protocols

Established procedures for accurate collection, tracking, storage, and management of clinical research data with high accuracy.

Oversaw subject recruitment and study enrollment goals.

Developed project schedules, targets, measurements, and accountabilities, as assigned. Led team meetings and prepared/approved minutes.

Collaborated with principal investigators and study sponsors, monitored and reported serious adverse events, and resolved study queries.

Developed study budget with staff and principal investigator, identifying standard of care versus study procedures.

Ensured regulatory compliance. Regularly inspected study documents to ensure ongoing regulatory compliance.

Worked with principal investigator to ensure Investigational New Drug applications were submitted to the FDA when applicable.

Research Specialist

Lombardi Comprehensive Cancer Center - Georgetown University June 2019 - September 2020, Washington DC

Managed full lifecycle of clinical trials (Phase I, II, III, IV), for the Hematology-Oncology Research Program.

Collaborated with a diverse range of stakeholders including principal investigators, data coordinators, clinic and hospital staff, regulatory and finance personnel, trial sponsors, CROs, and vendors to ensure the smooth operation and maintenance of research projects.

Oversaw and directed clinical research studies, ensuring adherence to protocols, patient recruitment and screening, and precise data collection and analysis, resulting in a 20% surge in study enrollment and on-time project completion.

Monitored study progress, identifying conflicting issues and inconsistencies in protocol requirements, safety data, patient eligibility, and laboratory test results.

Monitored and maintained regulatory documents site, including informed consent forms, clinical protocols, and amendments.

Clinical Data Coordinator

Crown Hills June 2018 - June 2019, Nottingham, MD

Designed and implemented a secure user database and data analytics platform, enabling the organization to collect and analyze patient data securely.

Improved reliability and accuracy of data records and consolidated data from multiple sources, resulting in a 75% increase in data entry accuracy and reduced data entry time by 45%.

Provided insights from analysis to develop evidence-based progress reporting solutions and optimized data sharing and collaboration among research departments.

Implemented a system for tracking and managing data backlogs; reduced backlogs by 40% in the first quarter.

VOLUNTEERING

Project Coordinator

Paten Pathway International • May 2018 - Present

Oversaw a team of 15 volunteers, implementing efficient scheduling strategies and delivering comprehensive patient care training, leading to a remarkable 50% decrease in wait times for underserved communities in West Africa

Collaborated with cross-functional teams to obtain project milestones and timeline requirements, created and maintained project schedules, and tracked project progress and deliverables to ensure successful on-time delivery of projects.

Used project coordination tools to manage several projects, leading to over 98% successful completion rate and 20% faster execution speed than expected.

CLINICAL EXPERIENCE

Resident Doctor October 2016 - April 2018

Lagos State University Teaching Hospital - Lagos, Nigeria

Medical Officer August 2014 - August 2015

National Neuropsychiatry Hospital - Lagos, Nigeria

Senior House Officer December 2012 - December 2013

Federal Medical Centre - Abeokuta, Nigeria

Medical Doctor Nov 2011 - November 2012

Borsod-Abauj-Zemplen County Hospital - Miskolc, Hungary

SKILLS

Onsite Monitoring

Clinical Trials

Trial Master File (TMF)

Communication

Data Management

ICH/GCP

Microsoft Office

Interpersonal Skills

Regulatory Compliance

Problem-Solving

Teamwork

EDUCATION

Harvard Medical School Postgraduate Medical Education, Global Clinical Scholars Research Training Program, 1-year Certificate Program (2022-2023)

Havard Medical School • Boston, MA • 2023

MD

University of Szeged • Szeged, Hungary • 2011



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