Atlanta Center for Medical Research

Scope

GENERAL SUMMARY OF DUTIES

Promotes good clinical practices in the conduct of clinical investigations. The Investigator assumes responsibility other than those responsibilities specifically intended for the PI. Ensures adherence to protocol requirements, protects the rights and welfare of subjects, assures the integrity of data generated at the site and directs the conduct of the clinical investigation according to federal and state regulations and guidance documents.

Duties

PROVIDES INVESTIGATOR QUALIFICATIONS AND AGREEMENTS

  • Demonstrating the proper education, training and experience to conduct the clinical investigation
  • Assuming responsibility for the conduct of the clinical investigation
  • Signing the Form FDA 1572 as appropriate
  • Signing the protocol as required
  • Signing sponsor contract(s) as appropriate
  • Documenting the financial aspects of the trial

    ENSURES PROTOCOL COMPLIANCE

  • Possessing a thorough understanding of the requirements of each protocol
  • Reviewing the inclusion/exclusion criteria, schedule of visits, end point criteria
  • Document adequate medical history for each study participant

    MANAGES THE MEDICAL CARE OF PARTICIPANTS

  • Ensuring that a qualified physician (PI or sub-investigator) is responsible for all trial-related medical decisions
  • Assessing subject compliance with the test article and follow-up visits
  • Assessing subject’s response to therapy
  • Evaluating for adverse experiences
  • Ensuring that medical care is provided to a subject for any adverse event(s)
  • Informing a subject when medical care is needed to treat an inter-current illness(es)

    ENSURES DOCUMENTATION OF STUDY-RELATED PROCEDURES, PROCESSES AND EVENTS

  • Documenting deviations from the approved protocol
  • Documenting and explaining premature unblinding of the investigational product(s)
  • Documenting that informed consent has been obtained from the subject or legal representative
  • Ascertaining the reason for a patient’s premature study withdrawal
  • Documenting adverse experiences
  • Complying with written procedures to document changes to data and/or case report forms
  • Maintaining trial documents as required by the regulations and sponsor for the appropriate timeframe and under secure conditions
  • Providing study reports as requested by the sponsor, IRB and regulatory authority(ies)

    DIRECTS SITE OPERATIONS

  • Communicating effectively with subjects, research team, IRB and sponsor
  • Meeting regularly with the research team to discuss subject participation and protocol progress
  • Ensuring that all research staff are informed about the protocol amendments and investigational agents
  • Being knowledgeable about regulatory requirements and GCP standards
  • Preparing for and attending investigator and start-up meetings
  • Making available to monitors, auditors, IRB and regulatory authority(ies) all requested trial-related records

    Qualifications

    Required: M.D., Ph.D., or Psy.D., with a focus in Psychology

    Preferred: Board Certified Psychologist/Psychiatrist, or Clinical Adolescent Psychologist

    Experience and training in the conduct of clinical trials

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