CYPRIAN AMOBI
New York,NY
Summary
Accomplished Senior Clinical Research Associate with a proven track record at Syneos Health, adept in clinical trial management and fostering investigator relations. Demonstrated expertise in ensuring study compliance and enhancing patient recruitment strategies, achieving significant enrollment milestones. Skilled in data management and committed to advancing clinical research with integrity and precision.
Overview
16
16
years of professional experience
Work History
Senior Clinical Research Associate
Syneos Health
05.2018 - Current
- Interacts with personnel from study sponsors, investigational sites, vendors, and other functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and other relevant regulations
- Develop recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones
- Document recruitment barriers and mitigation plans
- Performs protocol/site feasibility and Pre-Study Visits to recommend qualified sites
- Participates in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions and assists sites with study-related questions as needed
- Conducts IP accountability to ensure and verify compliance and correct / complete data via IWRS and e-pharmacy binder
- Provides feedback to study manuals, eCRF completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed
- Conducts Site Evaluation Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan and write the corresponding confirmation and follow-up letters
- Submits quality and on-time Monitoring Visit Reports and follow-up letters to the CTM for review and approval via Clinical Trial Management System
- Reviews ISFs to ensure essential documents are current and complete, and submitted to the TMF throughout the trial for reconciliation purposes
- Responsible for ensuring that the TMF is maintained in an inspection-ready state
- Handles site management tasks and ensures continuous data flow (i.e., on-time site data entry, query resolution, and source document verification)
- Assess the clinical research site’s patient recruitment/retention success and offer suggestions for improvement
- Ensures proper handling, accountability, and reconciliation of all investigational products and/or medical devices, and clinical trial supplies
- Prepares sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations
- Assisting and mentoring of junior CRAs on the team
- Assists the Clinical Operations team with additional related tasks as needed such as preparation and review of work instructions, plans etc
Clinical Research Associate II
Athira Pharma
01.2016 - 05.2018
- Collaborated with personnel from investigational sites, vendors, and other functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and other relevant regulations
- Assisted the study team in identification of potential sites for participation in clinical trials
- Performed protocol/site feasibility and Pre-Study Visits to recommend qualified sites
- Participates in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions and assists sites with study-related questions as needed
- Provided feedback to study manuals, eCRF completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed
- Conducted Site Evaluation Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan
- Submitted quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or CTM for review and approval via Clinical Trial Management System (CTMS) as per timelines specified in the CMP
- Reviewed ISFs to ensure essential documents are current and complete, and submitted to the TMF throughout the trial for reconciliation purposes
- Responsible for ensuring that the TMF is maintained in an inspection-ready state
- Established regular lines of communication and administers ongoing protocol/study-related training to assigned sites
- Ensured proper handling, accountability, and reconciliation of all investigational products and/or medical devices, and clinical trial supplies
- Prepared sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations
- Submitted accurate and on-time expense reports
Clinical Research Associate II
Stryker
01.2014 - 01.2016
- Conducted Site Evaluation Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan
- Submitted quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Lead for review and approval via CTMS as per timelines specified in the CMP
- Reviewed ISFs to ensure essential documents are current and complete, and submitted to the TMF throughout the trial for reconciliation purposes
- Responsible for ensuring that the TMF is maintained in an inspection-ready state
- Established regular lines of communication and administers ongoing protocol/study-related training to assigned sites
- Handled site management tasks and ensures continuous data flow (i.e., on-time site data entry, query resolution, and source document verification)
- Assess the clinical research site’s patient recruitment/retention success and offer suggestions for improvement
- Ensured proper handling, accountability, and reconciliation of all investigational products and/or medical devices, and clinical trial supplies
- Prepared sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations
- Submitted accurate and on-time expense reports
Clinical Research Associate I
PPD
04.2011 - 01.2014
- Conducted initiation, interim/monitoring, and closeout visits in compliance with the approved protocol and local regulations
- Verified adequate investigator qualifications, training and resources, as well as sites facilities, laboratories, equipment, and staff
- Performed Source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per study protocol, SOPs, GCP and other applicable regulatory requirements
- Verified and reviewed adverse events, serious adverse events and other safety events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol and ALCOA guidelines
- Assisted in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides)
- Contributed to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
Clinical Research Coordinator
MD Anderson Cancer Center
03.2009 - 04.2011
- Completed certification requirements for assigned protocols
- Screened designated schedules or patient lists for eligible subjects
- Contacted, approached and verified potential subjects
- Screened, enrolled and consented eligible subjects
- Completed research study visits as delineated in assigned protocol and manual of operations set forth by sponsor and supervisor
- Completed Telephone follow-up and telephone reminder calls for study participants
- Scheduled research visits according to the study protocol
- Entered research data into a centralized database program and other study specific electronic databases such as EDC, IWRS etc
- Completed study documents and files some examples might include case report forms, worksheets and medical record notes
- Maintained confidentiality of patient documents and files
- Informed relevant clinical staff regarding subject protocol participation
- Assisted in other research related activities and projects as needed
- Collaborated regularly with the investigators and other research staff
- Consulted with medical records of outlying clinics and hospitals to obtain pertinent data and patient information
- Attended and participated in Investigator, site initiation and monitoring meetings as assigned
Education
Bachelor of Science - Pharmacy
UNIVERSITY OF BENIN
MSc. - In View
UNIVERSITY OF BENIN
Skills
- Clinical trial management
- Study documentation mastery
- Pharmacovigilance principles
- Vendor management experience
- Investigator relations
- Data management proficiency
Therapeutic Areas
- ONCOLOGY, Advanced Solid Tumors, Breast Cancer, Lung Cancer, Lymphoma, Kidney cancer
- CNS, Parkinson’s Disease, Neuropathy, Alzheimer’s Disease
- ENDOCRINOLOGY, Metabolic Disorders, Diabetes
- OPHTHALMOLOGY, Macular Degeneration, Cataracts, Macular Edema
- INFECTIOUS DISEASE, Covid-19
- MEDICAL DEVICES, Heart Valves, Stents
Timeline
Senior Clinical Research Associate
Syneos Health
05.2018 - Current
Clinical Research Associate II
Athira Pharma
01.2016 - 05.2018
Clinical Research Associate II
Stryker
01.2014 - 01.2016
Clinical Research Associate I
PPD
04.2011 - 01.2014
Clinical Research Coordinator
MD Anderson Cancer Center
03.2009 - 04.2011
Bachelor of Science - Pharmacy
UNIVERSITY OF BENIN
MSc. - In View
UNIVERSITY OF BENIN
Similar Profiles
Jessica Alejandra Mateos RodríguezJessica Alejandra Mateos Rodríguez
Senior Clinical Research Associate at Syneos HealthSenior Clinical Research Associate at Syneos Health
Korissa PayneKorissa Payne
Engagement Center Medical Information Support Spec at Syneos HealthEngagement Center Medical Information Support Spec at Syneos Health
Jaime BirtJaime Birt
Associate Director Clinical Trial Management at Syneos HealthAssociate Director Clinical Trial Management at Syneos Health