AMAKA ODU
DALLAS,GA
Summary
A US veteran and Clinical Research professional with over 7 years experience and a strong background in clinical research. I have demonstrated a strong work ethic, discipline, and commitment with attention to detail, adherence to protocols, and the ability to work in a team. I worked on diverse range of clinical trials, gaining valuable experience and my expertise extends to performing all types of on-site and remote site monitoring visits, including Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV). I have experience with both 100% Source Data Verification (SDV) as well as reduced SDV approaches. I am proficient working with various clinical and/or client-specific systems for trial management, such as Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS) and Interactive Web Response Systems (IWRS). My extensive experience, exceptional problem-solving skills, adaptability make me a highly capable and well-rounded professional in the dynamic and fast-paced environment of clinical research.
Overview
10
10
years of professional experience
Work History
Clinical Research Associate
Agios Pharmaceutical
03.2024 - Current
- Managed blinded and unblinded clinical supplies and performed IP accountability, reconciliation, and destruction
- (Performed on-site or remotely) qualification, site initiation, interim monitoring, site management activities and close-out visits
- Ensured accuracy, validity and completeness of data collected at clinical trial sites in accordance with the protocol, Monitoring Plan, and other associated trial documents
- Provided recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develop action plans
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- Assessed factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP), assessed site processes, conducted source document review of appropriate site source documents and medical record
- Verified required clinical data entered in the case report form (CRF) is accurate and complete and apply query resolution techniques remotely and on site
- Provided guidance to site staff as necessary, driving query resolution/quality compliance issues to closure within agreed timelines.
Logistics Specialist
US Army
08.2023 - 02.2024
- Maintained records of all incoming and outgoing supplies and equipment and Conduct regular inventory checks to ensure accuracy and availability of necessary items
- Coordinated the distribution and storage of supplies and ensure timely delivery of equipment and supplies to various units
- Ensured compliance with transportation regulations and safety standards
- Utilized logistics software to enter and manage supply data and generate reports on inventory levels, supply status, and other logistical metrics
- Adhered to Army regulations and policies regarding logistics and supply chain management and Implemented safety protocols for handling hazardous materials
- Supported logistics operations during deployments and field exercises.
Clinical Research Associate
Agios Pharmaceutical
04.2021 - 08.2023
- Performs start-up activities, Initiation, Interim and Close-Out monitoring visits
- Performs 100% or reduced SDV during on-site and remote visits using EDC and in-house local CTMS system for reporting
- Maintains regular site staff contacts, trainings, and query resolution support
- Reviews on-site Investigator files and ensures subject safety by overseeing timely and accurate AE/SAE reporting
- Participated in local interim analysis
- Delivers all relevant services/tasks in support of the planning and implementation of quality driven clinical trials, in line with established targets and strategies
- Implements and models proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to all visit types (Site Selection, Site Initiation, Monitoring, and Closure) for assigned sites and clinical trials
- Verifies safety reporting and the proper handling, accountability, and storage of trial product according to trial specifications, SOPs, ICH-GCP guidelines, and relevant regulatory requirements
- Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external stakeholders to develop and implement Corrective and Preventative Action Plans (CAPA)
Clinical Study Coordinator
NORTHSIDE HOSPITAL
05.2018 - 03.2021
- Interview participants, perform study assessments and administer cognitive assessment tests based on previous experience (or willingness to learn) Conduct follow-up phone or video calls with study participants, request and collect medical records, and other miscellaneous administrative tasks Collaborate with a multidisciplinary team made up of clinicians and regulatory consultants Supported subject/patient recruitment, retention, and awareness strategies
- Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
- Understood project scope and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
- And adapting quickly to changing priorities to achieve goals / targets
- Prepared for and attends Investigator Meetings and/or sponsor face to face meetings, participated in global Clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends Clinical training sessions according to the project specific requirements
Clinical & Budget Coordinator
GSK, Nigeria
01.2014 - 03.2016
- Responsible for project management, project coordination, and clinical coordination for study trials Performed site screening, project budgeting, investigational material inventory, reconciliation and audit reviews
- Provided clinical and technical support to clinical centres Designed and facilitated subject recruitment, retention, and awareness strategies
- Provided centre-level oversight, project management, project coordination, and clinical monitoring
- Collected data and followed research protocols, operations manuals and case report form requirements
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies Maintained compliance with study protocols covering patient care and clinical trial operations.
Education
Diploma Automated Logistical Specialist - Logistics And Materials Management
Quartermaster School
Fort Gregg-Adams, VirginiaBachelor’s in public administration -
University of Benin
Skills
- Wealth of experience and skills in managing all components of drug discovery trials, from start-up to database lock My knowledge of regulatory requirements, such as FDA and Health Canada, as well as adherence to ICH-GCP guidelines, ensures compliance throughout the trial process
- Strong understanding of therapeutic areas relevant to my role and responsibilities, enabling me to provide knowledgeable support
- Demonstrated technical expertise by staying up to date on new systems and technologies, while also staying informed about emerging trends and advances in the field
- Familiarity with Risk Based Quality Management (RBQM) principles and tools
- Ability to proactively identify and address potential risks This includes working closely with clinical investigators to assess and resolve site performance, quality, and compliance issues
- Proven experience in managing tight deadlines and maintaining integrity of Clinical Trial Tracking systems
- Strong leadership and people skills which contribute to successful relationship management with multiple internal and external stakeholders involved in the planning and implementation of clinical trials
- Ability to work both independently and as part of a team, whether onsite or remotely, highlights my adaptability and flexibility
- Excellent prioritization skills, enabling me to effectively manage workload requirements
- Technical skills; Proficient in using MS Word, Outlook, Excel, PowerPoint, Access, and OneNote
- Additionally, experience with various software systems commonly used in clinical research, such as EDC/eCRF (Medidata Rave, Veeva, Inform), CTMS (Impact, Siebel, Veeva CTMS, eTrack), IWRS (Endpoint, Signant Health, ), eTMF (Veeva Vault, Realtime CTMS), and Labs (Clario, Q2)
Therapeuticareas
- Oncology
- Multiple Myeloma – Phase 3 – Double blind
- Infectious Diseases
- Hepatitis B – Phase 3 – Double Blind
- Malaria – Phase 1 &2 – Double Blind (Vaccine)
- Human Immunodeficiency Virus – Phase 2
- Gonococcal infections- Phase 2 – Double Blind
- Metabolic Disorders
- Ulcerative Colitis ( Pediatric) – Phase 3 – Double Blind
- Chronn’s Disease – Phase 3 – Double Blind
- Diabetic Peripheral Neuropathic Pain (DPNP) – Phase 2
- Dermatology
- Urticaria – Phase 3 – Double Blind
- Respiratory
- Respiratory Syncytial Virus – Phases 2&3 – Double Blind (Vaccine)
- Others
- Knee Osteoarthritis- Phase 2
Timeline
Clinical Research Associate
Agios Pharmaceutical
03.2024 - Current
Logistics Specialist
US Army
08.2023 - 02.2024
Clinical Research Associate
Agios Pharmaceutical
04.2021 - 08.2023
Clinical Study Coordinator
NORTHSIDE HOSPITAL
05.2018 - 03.2021
Clinical & Budget Coordinator
GSK, Nigeria
01.2014 - 03.2016
Diploma Automated Logistical Specialist - Logistics And Materials Management
Quartermaster School
Bachelor’s in public administration -
University of Benin
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