A Clinical Research Associate (CRA) works with a variety of individuals and teams involved in clinical trials, both within their own organization and externally. Here are some of the key groups they interact with:
Clinical Research Coordinators: These are often the primary contact persons at the site conducting the trial. CRAs work closely with them to monitor the trial and resolve any issues.
Principal Investigators: These are the individuals, typically doctors or other healthcare professionals, who are responsible for conducting the clinical trial at a site. CRAs interact with them to ensure the trial is being conducted in accordance with the protocol and regulatory requirements.
Sponsor's Clinical Team: CRAs are often employed by or work on behalf of the sponsor of the trial, such as a pharmaceutical or medical device company. They interact with various teams within the sponsor's organization, such as the clinical operations team, data management team, and safety team.
Regulatory Authorities: Depending on their role and the specific trial, CRAs may interact with regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Patients: While direct interaction with patients in the trial is usually limited, CRAs may occasionally interact with patients, such as during site visits.
Contract Research Organizations (CROs): Many sponsors outsource their clinical trials to CROs. If a CRA is employed by a CRO, they would work with the teams within the CRO and represent the sponsor at the trial sites.
Ethics Committees / Institutional Review Boards (IRBs): These are the bodies that approve and oversee the ethical conduct of the trial. CRAs may interact with them to submit necessary documentation and address any questions or concerns they have.
Pharmacovigilance / Safety Team: CRAs often interact with these teams to ensure that any adverse events or safety issues are properly reported and followed up.
Remember that the exact nature and extent of a CRA's interactions with these groups can depend on many factors, including the size and type of their organization, the specific trials they work on, and their level of experience.