Master of Science - Biomedical Informatics
University of Maryland Global Campus
Hyattsville, MD10.2025
SAMSON OJOMO
White Plains,Maryland
Summary
A well-qualified clinical research professional that is successful at building and maintaining secure, accurate, and efficient data collection systems. Hardworking and pragmatic with strong attention to detail and methodical approach. Prepared to offer extensive years of experience in the fast-paced position with room for advancement.
6-years combined Clinical research and Laboratory Technologist, Hospital experience Thorough knowledge of FDA and GCP principles and regulations Electronic Trial Master Files (eTMF) Design, use and review of Case Report Forms (eCRFs) Field Monitoring visits (PSVs, SIVs, IMVs and COVs) to meet study expectations Source data/document verification (SDV) Proficiency in reviewing protocol compliance, focusing on inclusion/exclusion requirements Widespread clinical trial phases I II III Experience with GCP auditing and SAE reporting Leadership, problem solving and analytical skills. Highly proficient with Veeva Vault, IMPACT Microsoft Office: Excel, Access, Power-point and Outlook Strong organizational, computer and problem-solving skills
Education
Bachelor of Science - Computer Networking And Cybersecurity
University of Maryland Global Campus
Hyattsville, MD05.2023
Bachelor of Science - Computer Science
University of Applied Science And Management
Port Novo - Benin03.2015
Skills
- Six 6 plus years of sites monitoring experience
- Able to comply with safety standard
- Excellent verbal and written communication skills
- Experience with computer literacy in clinical software applications
- Experience in Phases I - Phases III Clinical Trails
- Adverse event reporting
- Coordinating site operations
Timeline
Senior Clinical Research Associate
Parexel
05.2021 - Current
Clinical Research Associate II
ICON Clinical Research
12.2019 - 04.2021
Clinical Research Associate I
ICON Clinical Research
10.2017 - 11.2019
Clinical Research Manager
Medstar Washington Hospital Center
06.2016 - 09.2017
Clinical Research Coordinator
Medstar Washington Hospital Center
04.2014 - 05.2016
CompTIA A+
Master of Science - Biomedical Informatics
University of Maryland Global Campus
Bachelor of Science - Computer Networking And Cybersecurity
University of Maryland Global Campus
Bachelor of Science - Computer Science
University of Applied Science And Management
Work History
Senior Clinical Research Associate
Parexel
05.2021 - Current
- Verifies the quality of all recorded data for accuracy, completeness, integrity,and ensures timely resolution of all data queries remotely or at investigator site.
- Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
- Assist in the preparation and submission of regulatory documents, including Institutional Review Board (IRB) submissions.
- Verifies that written informed consent (ICF) was obtained before each subject’s participation in the trial.
- Assists in the development of trial materials as needed
- Developed Clinical Monitoring Plans with a review from the CRA Manager
- Managed periodic audits of client TMFs as well as internal TMF audits
Clinical Research Associate II
ICON Clinical Research
12.2019 - 04.2021
- Verified adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
- Supported study management team to ensure that studies are conducted in adherence to study protocols, applicable SOPs, and ICH/GCP guidelines.
- Conducted source documentation verification (SDV) against case report form data/EDC, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.
- Reviewed and verified adverse events (AE), serious adverse events (SAE), and concomitant medications to confirm accurate data reporting in accordance with the protocol
- Provided support to site staff including research coordinators and physicians
- Coordinated shipment of study-related material and notify team members of any missing or incomplete documentation
- Generated reports for Project Manager and clients, compose meeting minutes and distribute to appropriate parties
- Liaison between Project Manager, Regional Clinical Research Associates, Principal Investigators, site personnel, third party vendors and other study team members providing specific study information
- Managed study specific project tracking files and databases to include the Trial Master File and perform periodic audits
- Conducted field monitoring visits to investigative sites; assisting with source data validation, query process, drug accountability, regulatory review and collection of essential documents
Clinical Research Associate I
ICON Clinical Research
10.2017 - 11.2019
- Performed site monitoring visits such as selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and regulatory requirements
- Worked with sites to drive and track subject recruitment in line with study needs, to enhance recruitment at the site.
- Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project/study expectations and issues.
- Evaluated the quality and integrity of study site practices related to the protocol, adherence to applicable regulations, and escalated quality issues as appropriate.
- Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Managed periodic audits of client TMFs as well as internal TMF audits and verified that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Clinical Research Manager
Medstar Washington Hospital Center
06.2016 - 09.2017
- Oversaw day-to-day study-related responsibilities, which may vary with each clinical trial.
- Acted as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
- Coordinated and managed various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Prepared site for assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out.
- Communicated effectively with monitors for scheduled monitoring visits and developed future research study opportunities at our site.
- Assisted with the creation and submission of IND and IRB applications and is responsible for internal regulatory oversight
- Trained other Clinical Research Study Team members
- Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy
Clinical Research Coordinator
Medstar Washington Hospital Center
04.2014 - 05.2016
- Prepared and maintained Institutional Review Board (IRB) and regulatory paperwork to comply with institutional regulatory requirements
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Collected data from studies and enters information into the designated forms/database (EDC) to comply with study protocols and guidelines.
- Organized and maintained research records, data, and resources
- Interfaced with research participants, determined eligibility, and consented study participants according to protocol.
- Respond to data queries and other requests from data coordinators and study monitors in a timely manner.
- Assisted in developing recruitment strategies and conducting screenings for study participants
- Worked with CRAs to schedule monitoring visits
Affiliations
- Member Clinical Laboratory Scientist
- Member of the Association of Clinical Research Professionals (ACRP)
- Society of Clinical Research Professional (SoCRA) member
- NCURA Graduate Student Author
Therapeuticareas
- Oncology: Breast Cancer, Solid Tumors, Lung Cancer
- Neurology: Neuropathic pain, Huntington Disease
- Endocrinology: Type I & II Diabetes/ Diabetic Foot Ulcers
- Gastroenterology: Carcinoid Syndrome Diarrhea & Stomach Pain
- Medical Device: Cardiac Pacemaker
Overview
11
11
years of professional experience
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