Accomplished Clinical Research Associate with 7 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Skills
Trial methodologies
Meeting reporting
Patient recruitment
Completing regulatory documents
Protocol adherence
Report writing
Developing study tools
Database locking
Data Collection
Project monitoring
Subject tracking tools
Project Management
Microsoft Office Applications (Word, Excel, PowerPoint, Outlook)
Clinical Research Associate IIClinical Research Management – Frederick, MD,
Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
Processed specimens for clinical trials, sample storage and assay to provide registry of samples for test development, validation and analysis.
Followed drug storage procedures to comply with protocols and SOP requirements.
Implemented electronic data capturing systems to adhere with clinical research guidelines.
Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
Established drug trial methodologies and procedures to support business and clinical trial endeavors.
Perform and documented pre-study site evaluations, site initiations, regulatory documentation collection, interim monitoring and study close out visits in accordance with Good Clinical Practice.
Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Ensure site IRB approval and all IRB documentation were in order.
Maintained international Air and Transportation Association (IATA) training for routine packaging, labeling and the transportation of biological materials.
Maintained current Occupational Safety and Health Administration(OSHA) training regarding blood borne pathogens
Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
Reconcile contents of Investigator Site File(ISF) with the Trial Master File.
Ensure compliance to all applicable local requirements, FDA and ICH guidelines
Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
Document research participants who are lost to follow-up, or who have dropped out
03/2018 to 05/2019
Clinical Research CoordinatorVirginia Eye Consultants – Columbus, OH,
Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
Collected data and followed research protocols, operations manuals and case report form requirements.
Maintained compliance with protocols covering patient care and clinical trial operations.
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Pre-screened potential research participants to determine their initial eligibility and interest in a research study and adhering to important guidelines to protect
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Understood and complied with rules for billing Medicare, Medicaid and third party payors for services, drugs, devices, test, and procedures rendered in the clinical research context.
Monitored unit budget to meet financial objectives for spend rate and funding.
Completed all paperwork, recognizing any discrepancies and addressing them in a timely fashion.
Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting.
Worked effectively with multidisciplinary, ancillary and inter-professional research teams.
Ensured that non-serious and serious adverse events are properly identified, documented and reported per all applicable requirements
Developed and implemented performance improvement strategies and plans to promote continuous improvement.
Presented investigator with relevant information for determination of seriousness, causality and intervention .
Used coordination and planning skills to achieve results according to schedule.
Stored test articles supply according to FDA regulations and sponsor requirements.
Responsible for following the billing matrix/billing plan generated by administration for research participants enrolled in clinical studies.
Maintained study source documents(e.g. surgical reports, pathology reports, medical history laboratory reports)
Followed informed consent processes and maintained records.
Managed quality assurance program, including on-site evaluations, internal audits and customer surveys.
Accurately completed and maintained case reports forms (paper and EDC)
Monitored all company inventory to ensure stock levels and databases were updated.
Assisted in International Review Board (IRB) submissions and other related regulatory forms (e.g. radiation safety).
Maintained current Occupational Safety and Health Administration (OSHA) training regarding blood borne pathogens.
Ensured proper collection, processing and shipment of biospecimens.
Eliminated downtime and maximized revenue by providing top project quality control.
Facilitated site qualifications, study initiation and monitoring visits
07/2017 to 05/2018
Clinical Trial AssociatePlanet Pharma – Emeryville, CA,
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Assisted the Clinical Team Lead (CTL) and Clinical Research Associate (CRAs) with accurate updating and maintaining clinical systems that tracked site compliance and performance within project timelines.
Assisted the clinical team in preparation, handling. distribution, filing and archiving of clinical documentation and reports according to th scope of work and Standard Operating Procedures.
Assisted the CTLs with preparation, handling and distribution of clinical trial supplies and maintenance of tracking information.
Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
Maintained compliance with protocols covering patient care and clinical trial operations.
Demonstrated respect, friendliness and willingness to help wherever needed.
Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting.
Used Microsoft Word and other software tools to create documents and other communications.
Showed awareness and knowledge of applicable clinical research regulatory requirements i.e Good Clinical Practice (GCP) and the International Conference on Harmonization (ICH) guidelines preferred.
Exceeded goals through effective task prioritization and great work ethic.
Prepared a variety of different written communications, reports and documents to ensure smooth operations.
Detailed and accurate in working with the ability to establish and maintain effective working relationships with co-workers, managers and client.
Resolved problems, improved operations and provided exceptional service.
02/2014 to 05/2016
Clinical Research AssociatePatientiq – Chicago, IL,
Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Collaborated with Research Staff to design appropriate data collection tools (human subject calendars, schedules, tracking logs) to ensure collection was performed effectively, within established time frames and in compliance with GCP.
Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
Followed drug storage procedures to comply with protocols and SOP requirements.
Implemented electronic data capturing systems to adhere with clinical research guidelines.
Established drug trial methodologies and procedures to support business and clinical trial endeavors.
Created and maintained database and records filing system to document data on specimen collection, processing and storage.
Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease.
Ensured compliance to all applicable local requirements, NAFDAC and ICH guidelines.
Liaised with clinical project leader to effectively resolve study-related issues.
Processed specimens for clinical trials, sample storage and assay to provide registry of samples for test development, validation and analysis.
Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
Submitted routine Clinical reports and follow-up letters to facilitate internal and external communication.
Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
Education
Expected in 11/2015
Master of Science: Genetics And Biotechnology University of Ibadan - Nigeria , GPA:
Expected in 05/2012
Bachelor of Science: Animal Genetics Univeristy of Ibadan - Nigeria, GPA:
Expected in 07/2008
High School Diploma: Sacred Heart Collge - Ibadan, Nigeria , GPA:
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