Edith Okotie

Experience

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  MD Anderson Cancer Center

  Aug 2012 - May 2014

  Clinical Research Coordinator in oncology

  Served as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out.Determined eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.Coordinated collection of study specimens and processing.Collected and managed patient and laboratory data for clinical research projects. Managed research project databases, developed flow sheets and other study related documents, and completed study documents/case report forms.Ensured compliance with research protocols, and reviewed and audit case report forms for completion and accuracy with source documents. Prepared regulatory submissions, and ensured Institutional Review Board renewals are completed.Assembled study kits for study visits, monitored scheduling of procedures and charges, coordinated documents, and attend monitoring meetings with sponsors acting as primary contact.Interacted with the principal investigator regularly, ensuring patient safety and adherence to proper study care. Show less

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  AstraZeneca

  May 2014 - Jan 2016

  Clinical Research Associate II

  Performed clinical monitoring activities (site evaluation, initiation, interim monitoring visits, remote, and close-out) and provided overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.Created thorough monitoring visit reports.Verified eligibility for enrolled subjects.Regularly reviewed maintenance of required documentation in the Investigator File and/or Regulatory Binder; in addition, provide required documentation to the clinical team/client for the Trial Master File (TMF) or electronic TMF.Reviewed supplies and assist site with ordering additional supplies as needed.Provided training to site staff on protocol requirements.Identified and discussed study issues and updates with PI and other site staff in a timely manner to ensure the success of the clinical trial.Report identified protocol, SOP or GCP deviations and ensured that corrective and preventative measures are implemented to prevent future occurrences, referencing and following internal SOPs for serious breaches of GCP, Fraud or Misconduct.Actively followed up with sites about pending action items and queries in a timely mannerProvided input into the development of clinical trial related documents including but not limited to: protocols, case report forms, informed consents, conventions/timelines, monitoring plans, site referencemanuals, pharmacy manuals, laboratory manuals, training materials, and initiation slide. Maintained study specific tracking via CTMS or other tools.Liaised with the Safety Department in the management of serious adverse events (SAEs) and reports, and ensure appropriate action is taken at the trial site in accordance with the appropriate Policies, Standard Operating Procedures (SOPs), study specific requirements, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and applicable local regulations. Show less

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  AstraZeneca

  Feb 2020 - now

  Senior Clinical Research Associate

  Conducts qualification, initiation, interim and close out visits at clinical trial sites.Documents visit activities in the monitoring visit report and communicate progress to site via confirmation and follow up letters, as per monitoring guidelines.Ensures trial site(s) follow the study protocol, GCP, SOPs and applicable regulatory requirements.Conducts source data review/verification according to monitoring plan.Verifies proper subject informed consent process is taking place and appropriate documentation is collected.Verifies eligibility for enrolled subjects.Regularly reviews maintenance of required documentation in the Investigator File and/or Regulatory Binder; in addition, provide required documentation to the clinical team/client for the Trial Master File (TMF) or electronic TMF.Verifies staff qualifications (including proper delegation and training) and resources (including facilities and equipment) and ensured that these remain at an acceptable standard throughout the duration of the clinical trial period.Conducts IP accountability and reviewed storage conditions to ensure compliance.Creates and conducts training sessions including investigator meetings and team trainings.Provides oversight and direction to study team members, including vendors, for study deliverables Show less