Jasmine S.

Experience

• 

  Merck

  Jan 2017 - May 2019

  • Performed on-site and remote source document verification, data review, study product reconciliation, and regulatory binder review.• Prepared visit reports and aided site staff in resolving deficiencies.• Developed and demonstrated understanding ofassigned therapeutic areas and applies knowledge to study and project- related issues.• Educated and trained site and study staff on study conduct, including compliance with FDA and ICH/GCP guidelines.• Collected and reviewed regulatory documents in compliance with guidelines and standards. Show less • Assisted in the preparation, handling, distribution, filing, and archiving of clinical study documentation.• Accurately maintained Trial Master File documentation to ensure audit readiness.• Supported the preparation, handling, tracking, and distribution of Clinical Trial Supplies.• Assisted with the completion, tracking, and management of Case Report Forms (CRFs), data queries, and clinical data flow.• Supported monitoring visits and resolve monitoring findings.• Assisted Clinical Operations team members with study-related duties as necessary Minimum. Show less

  • Clinical Research Associate

    Jan 2018 - May 2019

  • Clinical Trial Assistant

    Jan 2017 - Jan 2018
• 

  DOCS

  May 2019 - May 2020

  Clinical Research Associate

  • Performed on-site and remote source document verification, data review, study product reconciliation, and regulatory binder review.• Prepared visit reports and aided site staff in resolving deficiencies.• Developed and demonstrated understanding of assigned therapeutic areas and applies knowledge to study and project- related issues.• Educated and trained site and study staff on study conduct, including compliance with FDA and ICH/GCP guidelines.• Collected and reviewed regulatory documents in compliance with guidelines and standards.• Assisted in protocol, informed consent, and CRF design and review.• Appropriately resolved issues related to site monitoring and management with guidance from the Project Manager.• Made decisions independently and with some supervision from Line or Project Manager. Show less

• 

  Emmes

  May 2020 - Aug 2022

  • Oversees and conducts monitoring activities, including remote monitoring and risk-based monitoring.• Develops collaborative relationships with investigative sites and personnel.• Lead/manages assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.• Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites and performance.• Builds relationships with the Investigators and site staff to enhance productivity, as well as collaborate with management on protocol discrepancies, improving efficiency, data integrity, etc.• Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans.• Prepares regulatory submissions, monitor patient safety and address protocol deviation, data quality issues, drug accountability and identify process improvements for assigned sites. Show less • Performed on-site and remote source document verification, data review, study product reconciliation, and regulatory binder review.• Prepared visit reports and aided site staff in resolving deficiencies.• Developed and demonstrated understanding of assigned therapeutic areas and applies knowledge to study and project- related issues.• Educated and trained site and study staff on study conduct, including compliance with FDA and ICH/GCP guidelines.• Collected and reviewed regulatory documents in compliance with guidelines and standards.• Assisted in protocol, informed consent, and CRF design and review.• Appropriately resolved issues related to site monitoring and management with guidance from the Project Manager.• Made decisions independently and with some supervision from Line or Project Manager. protocol deviation, data quality issues, drug accountability and identify process improvements for assigned sites. Show less

  • Sr. Clinical Research Associate

    May 2021 - Aug 2022

  • Clinical Research Associate II

    May 2020 - May 2021
• 

  PPD

  Aug 2022 - now

  • Arranged and Attended Regular study team meetings on the trial level• Arranged and Attended Regular study team meetings on a local level• Attended Mini Monthly Investigator meetings and sent meeting invites and minutes• Reviewed monitoring reports within 5 days and if associated issues to report, flag to CTM• Supported in updating monthly KPI Tool and slide updates for Trial Review Meetings• Ensured awareness and understanding of local and global amendments• Assisted CTM in completion of requested tasks• Followed up with site staff and investigator on action items• Checked ordered and shipped relevant material to the sites• Participated in Audit and inspections - Site level• Participated in Audit and inspections - OPU level• First and primary point of contact for all site needs• Maintained FAQ on a weekly basis• Documented and reviewed any questions that needed to be discussed during local trial team meetings• Ensured awareness and understanding of monitoring manual updates• Sent blast emails and/or newsletters to sites with updates/reminders• Referred all queries (vendor and DM) as needed to appropriate persons.• Followed-up with Site/SMM on resolution of queries and all EDC findings• Resolved COPI/GENIE queries in CTMS*• Ensured resolution of GPV safety queries and be main point of contact for reconciliation with Site.• Assisted with review of Investigator fee payments• Assisted with preparation of submission documents according to local regulations• Identification of potential investigational sites and oversight the site evaluation process• Vendor oversight including CROs, imaging, central lab, and EDC vendors• Addressing escalated site & study issues• Facilitating recruitment efforts by coordinating/planning Investigator Meetings, review of the study newsletter, face to face meetings with investigators, and creating recruitment plans on a site by site and study level Show less • Data cleaning process and governance accomplished within the required timelines across the trial with 100% clean data and no database unlocks.• Coordinated activities of extended clinical project teams consisting of over 15 internal and external personnel to ensure high level of performance in the planning, initiating, managing, and completion of clinical studies. • Cost effective management of budget and overseen of productively planning to ensure unforeseen overturns.• Participated in site selection, qualification, monitoring and ongoing site/investigator support.• Wrote and maintained Monitoring, Data management and Communication Plans.• Determines and regulates research staff workloads and protocol assignments; serves as a link to principal investigators in management of staff. • Coordinated with all relevant groups (e.g., Data management, Global Clinical Supplies) to develop clinical protocol timelines. Show less

  • Clinical Trial Manager

    May 2023 - now

  • Clinical Trial Manager

    Aug 2022 - May 2023