The Clinical Research Team and Their Roles

Clinical research is no longer limited to large organizations and institutions. Private practices, specialty clinics, and  smaller community-based providers are increasingly participating in clinical trials. They are finding these clinical research activities are helping to expand their patient care options and create new revenue streams.

In order for an investigative site to run a clinical research there are specific individuals they need. Roles and duties are clearly outlined for these individuals to ensure the success for a clinical trial.

How the Clinical Research Process Works

For a detailed overview of the clinical trail process check our our article that provides a overview of clinical research. Briefly, every clinical trial follows a structured pathway similar to below:

1. A sponsor such as a pharmaceutical or biotech company develops a study protocol for an investigative product 

2. Research site(s) such as clinics or medical offices are selected 

3. The study is set up and run following standard operating procedures established by the sponsor to include regulatory approvals and staff trainings

4. Patients are recruited and enrolled into the study

5. Data is collected according to strict guidelines for use off the investigative process in patients

6. The study run through multiple trial phases, it is monitored, audited, and eventually closed 

7. The Sponsor hopes that the investigative product is approved and brought to market.  

While this may sound complex, most of the operational workload is handled by a dedicated research team or research organizations such as Site Management Organizations like TriStar Clinical Research consulting (TriStar CRC). This allows physicians to focus on clinical oversight.

Your Clinical Research Team: Who Does What

A successful clinical trial site operates through a clearly defined team structure. The size of the site or the complexity of the trial may involve multiple roles, though there are some vey roles that are seen in the majority of trials. Understanding these roles is key to understanding your level of involvement as a provider.

Principal Investigator (PI)

The Principal Investigator is usually the physician that owns or runs  the investigative site. They are responsible for maintaining overall oversight of the clinical trials as detailed on the regulatory documents, such as form FDA 1572. They are responsible for reviewing and signing off on clinical decisions and ensuring patient safety and protocol compliance. They are on site during trials in case there are any adverse effects to the patient as a result of the trial investigation.  

While the PI is accountable for the investigation, they often delegate many of the tasks to qualified staff after appropriate training. Or if they are working with a Site Management Organization such as TriStar Clinical Research consulting, LLC they would delegate tasks to the SMO. This helps make the clinical research feasible for the provider and their busy schedules. 

Clinical Research Coordinator (CRC)

The Clinical Research Coordinator is one of those individuals the PI may delegate the majority of the trial tasks to. The CRC is often the operational backbone of the study and manages the day-to-day activities. They schedule patient visits and  ensure protocols are adhered to. They will interact directly with the patients for consent and to collect relevant clinical trial data. They are typically responsible for the patient progress and follow-ups to ensure the study is completed. 

Individuals in this role typically are employed by the investigative site. While an advanced degree is not necessary appropriate training for the clinical trial ad clinical procedures is essential. For many potential sites, training or hiring an experienced CRC is one of the largest barriers to engaging in lineal res reach. This is where external support from a SMO can jump start this process. 

Clinical Research Associate (CRA) – The Monitor

The Clinical Research Associate or monitor is an important part of the clinical research team. They are not engaged in the da to day nor are they employed by the investigative site. CRAs work on behalf of the sponsor or a contract research organization (CRO) to ensure trial compliance. 

They will visit the site every 6-8 weeks to review study protocol compliance and overal compliance. They will perform source data verification to ensure data is collected , transcribed and submitted according to regulations and requirements. They are looking to see if there are any study protocol deviations so they can report those to the sponsor or CRO. 

Unlike the CRC, the CRA does not interact with patients. Instead, they act as a quality control layer to ensure the integrity of the study.

What This Means for Your Practice

One of the most common misconceptions amongst physicians interested in clinical trials is that they much take on the full operational burden themselves. In reality as a PI they are responsible for oversight but not full executions. A CRC or appropriate external partner can support the startup, training, and ongoing trial management that is required. 

Support for clinical trials can help practices offer innovative treatments to their patients, diversify their revenue stream, and build long-term research capabilities. The key is having the right patters and structure in place from the beginning. This allows providers to stay focused on patient care while still participating in high-quality clinical research.

If you’re exploring how to bring clinical trials into your clinic, we help practices:

• Get set up from the ground up 

• Train staff and build internal capabilities 

• Provide ongoing support or full-service trial management 

Book a call or reach out through our contact form to discuss what a research program could look like for your practice.