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    Responsibilities of A CRA

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    A clinical research associate (CRA) plays a key role as the main link between the clinical trial sponsor and investigator. As the main responsibilities, a CRA performs clinical operations and monitoring. They work to plan, develop, conduct, and close out clinical trials by writing protocols and informed consent forms, developing case report forms, conducting site visits, overseeing study data, and reporting adverse events. A CRA's level is determined by their experience conducting these tasks and understanding of scientific methods and trial procedures.

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    Responsibilities of A CRA

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    api-3810976
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    A clinical research associate (CRA) plays a key role as the main link between the clinical trial sponsor and investigator. As the main responsibilities, a CRA performs clinical operations and monitoring. They work to plan, develop, conduct, and close out clinical trials by writing protocols and informed consent forms, developing case report forms, conducting site visits, overseeing study data, and reporting adverse events. A CRA's level is determined by their experience conducting these tasks and understanding of scientific methods and trial procedures.

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    Responsibilities of a CRA

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    A clinical research associate (CRA) plays a key role as the main link between the clinical trial sponsor and investigator. As the main responsibilities, a CRA performs clinical operations and monitoring. They work to plan, develop, conduct, and close out clinical trials by writing protocols and informed consent forms, developing case report forms, conducting site visits, overseeing study data, and reporting adverse events. A CRA's level is determined by their experience conducting these tasks and understanding of scientific methods and trial procedures.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    3K views15 pages

    Responsibilities of A CRA

    Uploaded by

    api-3810976
    A clinical research associate (CRA) plays a key role as the main link between the clinical trial sponsor and investigator. As the main responsibilities, a CRA performs clinical operations and monitoring. They work to plan, develop, conduct, and close out clinical trials by writing protocols and informed consent forms, developing case report forms, conducting site visits, overseeing study data, and reporting adverse events. A CRA's level is determined by their experience conducting these tasks and understanding of scientific methods and trial procedures.

    Copyright:

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    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    of 15

    Responsibilities of a CRA

    Dr.Pratibha Nadig
    ICRI,Bangalore
    Clinical research associate

     Key person in the clinical trial


     Major link between the sponsor and the
    investigator
     Performs both Clinical operations as well as
    monitoring
    Clinical research associate

    o Appointed by the sponsor or CROs

    Work independantly

     Location -Inhouse CRAs or field CRAs

     Levels- Upto 4
    CRA levels

     The levels are decided by the experience


     With experience a level 1 CRA will move to
    higher levels depending on
     Ability to evaluate a potential site with
    expertise,experience and patient resources,
     Better understanding of the scientific method
     Recognize the actions and procedures that would
    bias the study and invalidate the data
    1.STUDY PLANNING

     Write and edit protocols for clinical studies


     Co-ordinate review of protocol
     Write and review informed consent forms
     Identify and evaluate CROs.
     Identify and evaluate the Central labs.
    2.DEVELOPMENT

     Write and review sections of IND


     Design and develop CRFs
     Help in writing Ibs
     CRF Instruction manuals
     Determine the requirement,order, ship and
    track the investigational drug supplies
     Evaluate and select the investigators
    2.DEVELOPMENT

     Pre-study visit at the investigational sites


     Plan the investigators meetings and present
    sessions
     Review the investigators contracts
     Develop study budgets and the payment
    schedules
     Write and review protocol amendments
    3.STUDY CONDUCT

     Write and review annual IND reports


     Update the investigators brochure
     Conduct study initiation visits
     Conduct routine monitoring visits
     Oversight of CRO activities
     Mentain and track the study data
     Assist in data review and correction
    3.STUDY CONDUCT

     Review assess and interpret the study data


    Monitor and report adverse events

     Review the regulatory documents


    4.CLOSE OUT

     Conduct the study close out visits


     Perform post study follow ups
    5.POST STUDY

     Write and review the final study reports


     Archive the study files
     Assist with writing and reviewing sections of
    NDA
     Assist in response to any FDA inspections
    OTHERS

     Train and mentor new people


     Act as a project manager

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