Clinical Research Trials
Resume:
Esther Martins
Covington, GA
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PROFESSIONAL STATEMENT
I am a professional Clinical Research Associate with extensive experience working on various phases of clinical trials. My in-depth knowledge of ICH GCP guidelines and monitoring in multiple therapeutic areas gives me extensive experience in Study Feasibility and Study Start-Up activities. EDUCATION
Clinical Research Fastrack - Arizona, USA (January 2022 - February 2022) Olabisi Onabanjo University - Ago-Iwoye, Nigeria (1996 - 2001) EXPERIENCE
Clinical Research Fastrack
2022 - present
● Ensured internal and study-related training are complete per study timelines
● Served as first contact on assigned studies for site personnel
● Provided training to site personnel
● Conducted initiation, monitoring and closeout visits to verify study procedures
● regulatory documents and data completion
● Independently performed CRF review, query generation and resolution against
● Established data review guidelines on CTMS
● Identified and complete follow-up of SAE’s at study site while ensuring all procedure
● reporting and documenting is followed adequately per protocol requirements
● Confirmed study staff conducting the protocol have received the proper materials
● instructions and training to safely enter subjects into the study and complete the protocol requirements
● Actively participated in weekly trial cohort calls for a Phase I trial
● Ensured subjects protection by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
● Ensured the integrity of the data submitted on CFR’s or other data collection tools by careful source document review
● Ensured that site Regulatory Documents are complete and current throughout the duration of the trial
● Performed project plans related to clinical monitoring
● Assisted with data quality, CRF guideline development, and ongoing clinical data review
● Proficient in performing manual, in-house review of CRF data for completeness and accuracy and resolving data management and data query issues with study sites and CRAs
● Collaborated with team to maintain consistent CRF data quality and discrepancy resolution across sites
● Assisted in development of study tools and guidelines to be utilized by study sites
● Assisted in the potential investigators and sites selection process
● When monitoring independently, I will write monitoring reports per SOPs
● Communicates with sites and vendors and maintains effective management of study issues
● Conducted site visits (pre-study, initiation, interim and close-out)
● Reviewed sites informed consents against the consent template for presence of GCP requirements, protocol specific information and for accuracy
● Proficient in coordination and review of regulatory documents
● Ensure completeness, accuracy, and compliance at the site and in the Trial Master File (TMF)
● Assisted with sites and vendor’s issues and corrective action prevention plan resolutions
● Managed and monitored all aspects of clinical trials in accordance with study protocol, SOPs, ICH and GCP guidelines for clinical trials
● Responsible for site selection and study monitoring
● Ensured site compliance to drug safety and regulatory affairs
● Investigated and completed reports on patient safety and site safety issues
● Instructed sites on how to document and report AE, SAE and safety concerns
● Attended study start-up meetings
● Conducted source data verification
● Performed phone screen interviews for identified trial sites
● Assisted in trial site selection
● Make sure regulatory binders are up to date
● Ensured site-ensuring patient safety by adhering to protocol and abiding by the inclusion and exclusion criteria for each trial
● Ensured that written informed consent is obtained appropriately and prior to any procedures
● Wrote and submitted visit reports in a timely manner protocol guidelines
● Maintained proper filing of the essential regulatory documents and pharmacy binder
● Created source documents to ensure accurate data collection throughout the length of the study
● Recruiting, screening and enrolling patients in clinical trials
● Assisted in the submission of proposals involving research and human subjects (complete required forms) for IRB approval
● Dispensed and collected study drugs per protocol as well as maintaining a precise inventory on medications (on the pharmacy binder)
● Attended Site Initiation Visits (SIVs) for upcoming studies to gather the appropriate background knowledge
● Input data in Electronic Data Entry (EDC) programs as well as rectify queries
● Maintained Case Report Form (CRF) logs
● Compiled and added pertinent information to subject study charts in order to document each visit
● Scheduled appointments and made reminder calls to comply with study specific dates
● Conducted general study related tasks during subject visits: EKGs, Phlebotomy, Vitae
SKILLS
● Vast in use of different vendor systems and applications
● Core strengths: comfortable working in a team environment:
Possessing excellent communication skills
● Able to motivate team members and maintain productivity
● Talent for quickly learning new information, procedures, and regulations
● Well-detailed in report writing
● Exceptionally organized and able to multitask
AWARDS
Certified ICH GCP
REFERENCES
Upon request
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