Difference between In-house CRA and Field CRA

Field CRAs:

Filed CRAs are responsible for visiting sites in order to conduct some necessities that cannot be done remotely. These monitoring involves certain things as follows:

  1. Field CRA goes to sites for detecting any fraud.
  2. To make sure that the site staff is conducting research.
  3. To communicate with PIs and study coordinators related to the study and trials.
  4. For IP accountability in which the medicines are counted as what numbers of medicines are taken by the patients and what are left and what is the progress.
  5. For source data verification that includes gathering all the documents that contains all the details of the patients participating in the trial. This documented information is compared with the information added in the EDC system.
  6. Electronic source management on study trials.
  7. Building reports with the site staff for the sponsors.

In-House CRA:

In-house CRA have to fulfill their duties by sitting in their office and are responsible for certain tasks as follows:

  1. Collecting documents remotely and putting them into TMF by sitting in their office.
  2. Issuing inquiries remotely.
  3. Helping the site with the protocol reviews and in answering the queries.
  4. Making action item logs with site.
  5. Doing site qualification visits remotely.
  6. Making monthly monitoring calls.

CRA positions are not entry level position which cannot be achieved directly without having atleast two years of clinical research experience because two year experience is the demand of the sponsors. In-house CRA position can be achieved with little experience where they do not require and research related experience.

 

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