Who Works a Clinical Research Trial?

Who Works on a Clinical Research Studies or Trials?

The Sponsor overall is responsible for the trial conduct; however, the Sponsor outsource work to another company called a "Contract Research Organization" or CRO.  The Sponsor and CRO work together in overseeing the study.  There may be one or multiple CROs involved in a clinical trial.

The Sponsor or CRO will find different doctors called "Investigators" in many different locations who agree to follow the protocol and will administer the  Investigational Product at their clinic.  The lead doctor is called the "Principal Investigator" and manages oversight of the study at the clinic.  There may be additional staff (doctor, physician assistant, nurse practitioner) who are responsible for performing key study assessments and they are called "Sub-Investigators". The Investigator is assisted by a "Study Coordinator" (SC) or "Clinical Research Coordinator" (CRC) at the medical clinic who helps the doctor to manage the administration of the study.   A CRC can be a nurse, medical assistant, or other clinic staff.  A position that links the Investigator's sites to the Sponsor/ CRO is called a "Clinical Research Associate" or CRA.  The CRA works on behalf of the Sponsor or CRO to oversee the site.  This means reviewing all the study documents (medical records, trial data, study correspondence) to ensure that the clinical trial is being conducted according to the protocol and regulatory requirements.  If CRA provides training and feedback to the site staff to ensure to help them keep compliant.  Overall the Investigator is responsible for all work done at the site but the CRA works in collaboration with the site to make sure quality research is being performed.  The CRA travels to the different clinics to perform this review and mainly works with the CRC during these "monitoring visits".

Clinical research seeks to find cures for cancer, diabetes, genetic diseases, and more.  Clinical research professionals work as a team to innovate these medical breakthroughs.

This was a general overview of only some of the jobs that manage a clinical research trial or study.  A career in this field means learning how to protect the safety and well being of humans who participate in these trials while looking for the next generation of medical healthcare treatments.

The above information was tested for clarity in conversations with taxi cab drivers on trips to and from airports.

- Article by Laurel Latto, Certified Clinical Research Associate (CCRA)

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