Clinical research associates, also called clinical monitors or trial monitors, are in charge of monitoring clinical trials and assuring that regulatory, operational, and ethical standards are followed. CRAs connect sites with CROs and sponsors. CRAs typically work for pharmaceutical companies, government agencies, or medical research institutes, and often travel between study sites for monitoring visits and virtual visits. Many clinical research associates are trained as CRCs first.
A monitor or CRA evaluates the data on-site and raises queries with CRCs or relevant stakeholders for error correction. Moreover, monitors contact data managers in order to clarify data. CRO or pharma companies are good options for you if you are looking for CRA work. There is a lot to choose from in this field, and if you are a travel enthusiast, this could be an advantage for you.
Roles and responsibilities of a Clinical Research Associate
1. Finding and selecting an investigator to oversee the trial on the trial site. Liaising with doctors, consultants, and investigators about the trial.
2. The trial sites need to be set up, including making sure each center has the trial materials, including the trial drug, often called the investigational medicinal product. The study staff must be trained in the standard operating procedures as per applicable regulations.
3. Verify that the investigator and investigator’s team are appropriately trained and following the protocol.
4. Make sure that IRB/IEC operates according to GCP, SOP, and applicable regulations.
5. Monitoring trial sites during a specified period of time.
6. Verification of source data.
7. The review of informed consent forms, the review of case reports, the review of investigational drugs, and the review of adverse events.
8. Ensure that all unsold trial supplies are returned.
9. Preparing and filing trial documents and reports, writing visit reports.
10. Collecting trial documents and reports, writing visit reports.
Skills required to become a CRA
The required skills for a Clinical research associate are:
1. Ability to communicate effectively (both verbally and in writing) and build effective relationships with trial center staff.
2. Clinical research associates should have the capability of motivating others.
3. Pay attention to the details of the study.
4. You should be able to multitask and think quickly.
5. Job requires good organizational abilities, IT skills, and administrative skills – lots of documentation and recording information through computerized means, including clinical trial and management systems.
Salary of a clinical research associate
A clinical research associate earns up to 4-5 lakhs annually in India. The salary will increase gradually with experience and skills. In case you are handling one or a project you eventually will earn more than the average salary.