EVMS

  • Clinical Research Associate II

    Position Number
    2880705
    Department
    OB/GYN - CONRAD
    Category
    Research
    Compensation Max
    USD $103,054.00/Yr.
    Compensation Min
    USD $80,827.00/Yr.
    Location : Location
    US-VA-Arlington
  • Overview

    This position will monitor the administration of a clinical trial on behalf of a sponsor, assuring that the research site personnel and investigator conduct the study according to GCP guidelines, that all applicable regulatory requirements are being met at the investigator’s site and all applicable adverse events are properly reported to IRB/FDA and reports to the Senior Clinical Project Manager.  This position is located in Northern Virginia in Arlington, VA.

    Responsibilities

    • Identify and avoid non-compliance, misconduct, and fraud in clinical studies under review
    • Ensure Compliance with HIPPA authorization and privacy requirements.
    • Responsible for monitoring clinical studies to ensure compliance with good clinical practice (GCP) and in accordance with ICH and the FDA Code of Federal Regulations.
    • Detect problems proactively and implement corrective actions.
    • Audit clinical files, clinical sites and clinical data.
    • Utilize best practice techniques for clinical quality assurance
    • Prepare clinical studies for FDA bioresearch monitoring inspections
    • Draft and reviews protocols and protocols amendments.
    • Drafts models informed consents for study protocols and reviews site specific consent forms.
    • Assists in the identification of possible investigators for clinical studies and conducts pre-study visits to evaluate the appropriateness of clinical sites for a study.
    • Assists in case report form (CRF) design and review of draft CRF documents.
    • Coordinate electronic transfer of laboratory data between clinical study sites, central laboratory, and data management group.
    • Arranges for packaging, labeling, and shipment of clinical study supplies prior to study initiation, as necessary.
    • Assists in the preparation for and presentations at investigator meetings.
    • Helps conducts initiation meetings for new clinical studies.
    • Collects and reviews essential documents for study start-up and ensures documents remain current during the course of the trial.
    • Checks that adequate clinical study supplies are maintained at clinical sites.
    • Maintain timely and accurate documentation of clinical study process.
    • Alerts the medical staff and prepares written summaries of serious adverse experiences (AE), AE trends, treatment failures, and other unexpected events that occur during a study.
    • Assures that CONRAD Standard Operating Procedures (SOP’s), as detailed in the study protocol, are met prior to study initiation and during study conduct.
    • Assists in the drafting and reviewing of reports for completed studies.
    • Keep abreast of changes in regulatory requirements.
    • Assists the senior clinical team management with project workflow, tracing project milestones, developing timelines and accomplishing project goals.
    • Assists in the training of new Clinical Research Associates.
    • Performs other duties as assigned.

    Qualifications

    Bachelor's degree and four years experience in clinical research, including monitoring experience. 

    Location : Location

    US-VA-Arlington

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