Clinical Research Associate
Resume:
Ola-Yinka Ojerinde
*********@*****.***
EDUCATION:
Cert., FDA's Overview of Biosimilar Products 2022
Cert., FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond 2022
IN-View- 2021-Present
Clinical Trial Research Associate
Durham Community Technical College
Cert., Methodology & Strategic Development Resources University of East London, England, Uk
Bachelor of Science, Business Administration & Management Lagos State University, Ojo, Lagos
.
SKILLS
Microsoft office, Clinical Research, Clinical Data Management, Clinical documentation, GCP, HIPAA, Oracle Clinical, Clinical tracking system, Trial Master File, Regulatory Documents, CRF, DMP, SOP, medDRA & WHoDrug Coding,
Therapeutic Areas:
• Oncology
• Cardiovascular
PRACTICE:
CLINICAL RESEARCH SPECIALIST
Mount Sinai Medical Center, New York, NY 04/2024– Present
• Contributed to the development of clinical protocols, informed consent forms, and case report forms
• Designed recruitment strategies, recruit potential subjects, determine subject eligibility, and consent subjects according to the IRB/protocol approved methodologies
• Developed advertisement and other information materials for recruitment
• Performed subject interviews and study related nonmedical/behavioral interventions and neuropsychological battery testing assessments
• Determined appointments per protocol
• Scheduled and/or call subjects for appointments and follow-up visits
• Assisted in the conduct of study related non medical/behavioral assessments, perform study interview and testing
• Extracted data from source documents and assisted students with data entry. Complete case report forms and enter into database. Run database error reports during analysis Address and resolve queries/errors discovered during analysis
• Recorded, documented and reported protocol deviations. Communicate with PI/CO I on issues
• Maintained updated enrollment log for primary study and sub studies
• Created agenda for team meetings
CLAIMS ADMIN MANAGER PROPERTY & CASUALTY
Pilot Catastrophe, Richmond, TX. 01/ 2023- 11/2023
• Assist property loss adjusters in writing loss claims from Xact Analysis, and Xatimate software
• Documents all claims assigned to property loss adjusters, in other to be reviewed, addressed, and paid for in a timely manner
• Follow up adjusters on claims decisions as per policy coverages
• Addressed escalations from agents, contractors, customers, vendors, and other stakeholders
• Held and document daily meetings with management, and property loss adjusters
• Properly evaluate claim progress to ensure good practices, compliance with all SOP’s, laws and regulations from DOI
• Direct, give mentorship to loss adjusters as needed
• Documents and write daily reports to management
CLINICAL RESEARCH SPECIALIST
VCU Health, Richmond Virginia 11/2021-10/2022
• Provided project and study management and assures successful conduct of assigned clinical studies/projects
• Developed therapeutic and device operation knowledge and applies this knowledge to clinical study processes
• Established selection criteria for principal investigators and investigative sites and drives center selection process
• Responsible for site identification, qualification, initiation, training to ensure study compliance and subject protection
• Trained of investigators, center staff and Medtronic clinical staff
• Facilitated meetings with health care professionals for Investigator Meetings, Data Safety and Monitoring Boards/Clinical Events Committees, Advisory Boards Steering Committees, and Publication Committees
• Enlisted support and provides work direction for various clinical team members to assure timely achievement of milestones and study objectives, including development of a cohesive, high-functioning team.
Associate Clinical Research Specialist
Crozer Health, Philadelphia, PA 09/2020-10/2021
• Performed data collection through patient chart review, maintaining databases, obtaining participation consent and other forms from patients
• Maintained and manage study equipment, including troubleshooting/monitoring of subjects’ study computers
• Oversee proper handling of laboratory specimens including processes, shipping, storage, and documentation
• Assisted with budget development, invoicing for adverse events, billing compliance and patient billing resolution
• Identified and scheduled screening procedures and review results. Assist in the preparation for monitoring visits
• Provided guidance regarding project planning, project logistics, and project implementation
• Assisted in the development and writing of clinical trial monitoring plans CLINICAL DATA COORDINATOR
Dignity Health, Sacramento CA 12/2018-06/2019
• Managed service providers to ensure delivery performance standards are met
• Communicated effectively with all department to plan meetings
• Reduced time spent on all client’s data uploads
• Reviewed daily all data entries in the DBMS
• Create and deliver staff training sessions on best practices for streamlined and efficient work processes, database usage and data entry standard
• Oversee and manage all daily operations of the Data and Parcels department
• Work closely with customer service and operations team to ensure quick turnarounds and immediate responses to any issues
CLINICAL DATA ASSOCIATE
Dignity Health, Sacramento CA 07/2018-12/2018
• Underwent exclusive training on CRF designing, data validation, query management, safety data management to Involved in Double blind randomized parallel clinical trial
• Maintained clinical data accuracy through review of case report forms for completeness and consistency
• Working with cross functional teams to get clean data
• Reviewed the resolved discrepancies and closed where appropriate
• Produce the desired AE/SAE report and managing the clinical data intermittently as per 21 CFR USFA regulations
• Understanding the importance of the ICH-GCP guidelines along with USFDA
• Tracked study progress and issued periodic status reports
• Attending Clinical Trail Team meetings and representing the Data Management department
ASSISTANTT DATA MANAGER
Strictly Eagle Solution Ltd, London, UK 07/2012-06/2016
• Demonstrated up-to-date expertise in Information Systems and apply this to the development, execution and improvement of action plans by providing advice and guidance to others in the application of information and best practices
• Supported and align efforts to meet customer and business needs
• Managed customer relationships and expectations by developing a communication process to keep others up-to-date on project results
• Led and participated in multiple projects by completing and updating project documentation; managing project scope; adjusting schedules when necessary; determining daily priorities; ensuring efficient and on-time delivery of project tasks EXE. RISK UNDERWITER
Equity Assurance Plc, VI Lagos 03/2007-10/2011
• Underwriting Non - Life Risk Insurance policies for new and old clients
• Coordinated insurance brokers with the line manager
• Reconciled accounts of 12 regional state branches at the head office
• Conducted renewals of customer’s insurance policies at the head office
• Coordinated commissions of brokers, customer at the head office
• Input all data from head office and 12 regional state branches
• Computed brokers and customer’s commissions for easy access
• Completed inspections of all customer products for insurance except life insurance
• Coordinated claims papers for customer claims and loss adjusters TRAINEE, UNDERWRITER
Equity Assurance Plc, VI, Lagos 02/2007
• Inputted all data from 18 branches into the head office computer master file
• Re-entered and verified data by junior staff for accuracy
• Identified errors and discrepancies and routed to the appropriate personnel
• Followed all Standard Operating procedure
• Coordinated with multiple underwriters and claims department TECHNICAL SKILL
EDC Oracle clinical, Epic $ Cerner
Programming Language Working exp. With SAS team & applicable SAS
PROFESSIONAL SUMMARY
• In depth knowledge of Drug development process, clinical trial processes, data management, regulations (e.g., ICH-GCP, 21 CFR 11) and Quality Management
• Extensive experience in working with Phase II through Phase III of clinical trials using EDC systems
• Experience in working on various EDC databases including Medidata Rave, Oracle Clinical (RDC).
Hands on experience in performing process related quality assurance checks for assisting in the planning of investigator meetings, prepared investigator meeting materials, and presented on regulatory requirements at meetings Hands on Experience
• USE SPSS, L QUERIES, EXCEL, AND OTHER ANALYTIC TOOLS TO CLEAN AND ANALYZE DATA.
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