Briana S.

About Briana S.

Enthusiastic Clinical Research Associate eager to contribute to team trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 6 years of related experience to a challenging new process through hard work, attention to detail and excellent organizational skills. Well-versed in study protocols, standard operating procedures and GCP.

Experience

1. Senior Clinical Research Associate

   Merck

   Jan 2020 — Present · Dallas, TX, US

   Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.Responsible for multiple projects and must work both independently and in a team environment.Verifies that the investigator is enrolling only eligible subjects.Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.Verifies and supports the recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.Delivers high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.Provides mentorship, training and direction to Clinical Research Associates when needed.Responsible for the scheduling and conducting of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.Verifies the rights and well-being of trial subjects are protected.