Paul Meneses - Clinical Research Coordinator Resume Simple
SUMMARY
Clinical research coordinator with experience in phase II, III, and IV certified. I have extensive experience in the pharmaceutical industry. I have worked in the areas of study and research studies.
SKILLS
  • clinical trials, iv, file, ich, correspondence, research, quality, gcp, quality assurance, sops, implementation, compliance, fda, clinical, maintenance, documentation, supervisor
  • quality assurance, inventory, supervisor, iv, monitoring, quality, clinical, research, medical, clinical trials
WORK EXPERIENCES
  • 2017-12-252017-12-25

    Clinical Research Coordinator

    Credit Suisse

    • Perform quality assurance activities for the research studies, including but not limited to, protocol deviations, study file maintenance, and documentation of adverse events.
    • Ensure compliance with protocol, SOPs, GCPs, and FDA regulations. Perform clinical monitoring of all subjects in accordance with GCP and ICH guidelines.
    • Act as liaison between the Principal investigator and the sponsor to ensure that all study implementation and protocol requirements are met.
    • Assist with the collection of study recruitment materials for the hospital. Participate in the recruitment of potential subjects. Review and approve informed consent.
    • Coordinate and conduct pre-study, initiation, interim, and close out visits. Ensure that all clinical trials are carried out according to protocol, including but not limited to, source document verification, subject recruitment
    • Assist with the collection of study related documents, including but not limited to, informed consent, source document, and clinical trial materials.
  • 2017-12-252017-12-25

    Clinical Research Coordinator

    Electronic Data Systems

    • Assisted in the development and implementation of quality assurance and monitoring activities for the study and medical logistics. Conducted site visits, including: consenting, consent forms, and enrollment.
    • Research subjects for study visits, IV and SC, IM, SC, ID, and investigational drug. Clinical trial management.
    • Coordinate study visits, schedule appointments, audit operations, and other research related documents. Manage study logistics. Collect and process specimens.
    • Notifies supervisor of any adverse events or serious adverse events. Ensures that all study related documents are complete and accurate.
    • Manage study start-up activities, including: recruitment, participant consent, and drug accountability. Reconciliation of investigational drugs.
    • Ordering and maintaining investigational drug inventory for all trials. Maintain accurate and complete records of study activity. Assist with the preparation of IRB submissions.

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