Amina Salami
Summary
Competent CRA with over 9 years’ experience working with one of the leading CRO companies. Experience in
multiple therapeutic areas including Cardiology/Vascular diseases, Devices, Hematology, Infectious/Parasitic
diseases, Nervous System and Ophthalmology. Extensive understanding of clinical practices, clinical trial
methodology with knowledge of ICH, GCP and other Federal Guidelines.
Performed all types of on-site and remote Monitoring Visits: PSV, SIV, IMV and COV with 100% or reduced
SDV and rSDR in phases I-III. Used different clinical and/or client specific systems for trial management, such
as EDC, CTMS, IVRS, IWRS, eDiaries and participated in several site audits, local authority inspections and
supported investigative sites in preparation for FDA inspection. Excellent written and oral communications skills
and ability to build effective relationships with site staff and study team
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate
PPD (Contract)
Morrisonville, NC
04.2021 - 07.2023
- Responsible for planning, scheduling, and implementing the clinical aspects of projects in line with contract and budget, e.g., implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; IP management
- Interfaces with client and program/project staff; ensures provision of meeting agendas and summary documentation and /or detailed information as required for internal and client meetings
- Lead clinical team meetings and prepare sections for monthly, quarterly, and annual reports; and, present at internal meetings
- Ensure successful site startup, maintenance, and close-out
- Successfully deliver operational activities, such as study start up, site management, clinical monitoring, and data management activities
- Oversight of the management of sites to ensure compliance with the protocol, ICH-GCP, other relevant guidelines and applicable regulations, as well as SOPs.
Clinical Research Associate I-III
Covance
Durham, NC
05.2013 - 04.2021
- Coordinated and was responsible for the oversight of specific activities to ensure client and sponsor expectations are met in compliance with any phase study design
- Performed submissions and notifications to Regulatory Authorities, IECs and other bodies according to applicable guidelines, regulatory requirements and SOPs
- Identified potential unreported Adverse Events and Serious Adverse Events during patient interview and appropriately processes according to study protocol guidelines and sponsor SOPs
- Coordinated and conducts PSSV, SIV, and COV visits in order to assess the qualification of potential study sites, to initiate and instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected, and to terminate studies
- Supported the maintenance of clinical project documents, including Site and/or Data Management Plans, Monitoring Guidelines, Data Review Guidelines, Site Operations Manuals, and Monitoring Visit Letter Templates under guidance of Operational Team Lead
- Acted as primary point of contact for assigned study sites
- Tracked patient enrollment, study supplies, and data entry efforts for assigned study sites
- Monitored drug inventory, dispensing, compliance and return and ensures that used and expired medications are returned to the sponsor or disposed per pharmacy guidelines
- Trained and re-trained of new research personnel, including Study Coordinator, Investigators, and site pharmacists
- Conducted site equipment's inspection and site SOP to ensure patient safety and adherence to.
Clinical Research Coordinator
Richmond Hospital
Staten Island, NY
05.2012 - 04.2013
- Contributed to the achievement of established department goals and objectives and adheres to department policies, procedures, quality standards and safety standards
- Complies with governmental and accreditation regulations
- Regulatory responsibilities include the oversight and/or responsibility for the Intuitional Review Board (IRB) submissions, and other related regulatory forms (e.g., scientific review), and adhering to the timelines of the study start-up process; developing informed consent documents and other documents as applicable; supporting the safety of clinical research participants; ensuring the appropriate delegation of study related tasks (i.e., Delegation of Authority)
- Explained the informed consent process and the study to the research participant (e.g., purpose, duration, risks/benefits) and obtains all required signatures; ensures the research participant has sufficient time and opportunity to ask the investigator medical questions; documents the informed consent process in the source document and provides the research participant with a copy of the informed consent
- Developed an effective recruitment plan (e.g., central recruitment core); recruits research participants and discuss study protocol; educates research participants about protocol expectations and meets with research participants for each visit and maintains accessibility to discuss any questions or concerns regarding the study; oversees the development of advertising materials; participates in teleconferences and/or meetings to review study progress and conduct
- Data entry responsibilities included the completion and maintenance of case report forms and reviews data against the research participant's medical record for completeness and accuracy; addressing all queries, clarifications and outstanding data queries and appropriately communicating with the sponsor and/or Contract Research Organization (CRO); completing and submitting case report forms on as close to a 'real time basis' as possible
- Ensured proper collection, processing and shipment of biospecimens
- Study responsibilities include research participant interviews and assessments at study visits as required by protocol
- Received and maintained test articles from sponsor and inventory test articles
- Ensured that non-serious and serious adverse events are properly identified, documented and reported according to all applicable requirements
- Understood and complied with rules for billing Medicare, Medicaid and third-party payors for services, drugs, devices, tests, and procedures rendered in the clinical research context; responsible for reviewing, understanding and accepting the billing matrix/billing plan generated by administration for research participants enrolled in clinical studies; ensures research participant stipends have been routed in a timely manner as applicable
- Acts as a liaison with research participants, investigators, sponsors and healthcare professionals; prepares for site qualification, study initiation, monitoring and close-out visits.
Education
Bachelor of Science - Microbiology
UNIVERSITY OF ABUJA
12-2011
DeVry University
Downers Grove, ILSkills
- Good Clinical Practices
- Trial management
- Research SOPs understanding
- Informed consent
- Training and Development
- Excellent Communication
- Planning and Coordination
- Organization and Time Management
- Multitasking Abilities
- Self-Motivated
System Experience
- Microsoft Office (Word,Excel,Powerpoint)
- EDC (Medidata Rave, Inform, C3D, Captivate)
- CTMS (Veeva Vault)
- ETMF (Veeva Vault)
- IVRS(Almac,Clinphone)
- Concur
Therapeutic Area Experience
- Oncology
- Medical Device/Diagnostics
- CNS: Nervous System: Parkinson’s Disease,Multiple Sclerosis , Alzheimer’s Disease (1y), Retinopathy
of Prematurity
- Cardiovascular : Essential Hypertension, Stroke,Blood Glucose, Monitoring Device, Percutaneous Coronary Intervention
- Ophthalmology
- Endocrine
- Infectious Disease :Malaria ,HIV/AIDS
- Respiratory
- Vaccine: Covid
- General Medicine: Contraceptive Gel device , Orthopedic device
Nervous System: Parkinson’s Disease (2y), Multiple Sclerosis (1y), Alzheimer’s Disease (1y), Retinopathy
of Prematurity
Certification
•PPD Vaccines University Certificate Program, 2021.
•PPD Vaccines Academy Certificate Program, 2021.
Accomplishments
Awards And Honors
•PPD Spot Award, 2021
- PPD Spot Award, 2022
- Dean's List Fall 2023 (Devry university )
- Dean's List Spring 2020 (Devry University)
Timeline
Senior Clinical Research Associate
PPD (Contract)
04.2021 - 07.2023
Clinical Research Associate I-III
Covance
05.2013 - 04.2021
Clinical Research Coordinator
Richmond Hospital
05.2012 - 04.2013
Bachelor of Science - Microbiology
UNIVERSITY OF ABUJA
DeVry University