Clinical Research Associate (CRA)

Duties

There will be several tasks allotted to a CRA depending on the company, but some of them are presented here:

• Collaborates with investigators and research staff to successfully implement clinical trials in accordance with regulatory requirements and protocols.
• Evaluates that quality of materials and collected data, including supporting the on-site personnel with internal audits and inspection.
• Identifying and assessing sites as potential facilities for conducting clinical trials.
• Verifying the integrity of data entered on case report forms or (CRFs) in comparison with clinical notes of a patient.
• Preparing reports, research manuscripts for publication and other documents for record filing and collation.

Day In The Life

A day in the life of a CRA can differ greatly. Clinical trials are carried out at various stages and are conducted on healthy humans or patients suffering from a particular disease. Generally, your work schedule revolves around establishing secure trial sites, monitoring each and every trial and maintaining records of the procedure for study documentation.

Once trials are completed, you are also part of the team that closes down the site in compliance with industry standards and ensures that all unused trial supplies are flagged. Further, recruitment of efficient investigators or consultants for conducting clinical trials might be part of your work day.

If you are in a field-based role, you are likely to travel often – 3 to 4 days a week – and be on the road. Your day involves working alongside doctors and research nurses at trial centres or hospitals to supervise and evaluate duties regarding clinical trials. On the other hand, your role can be in-house at an office environment, where you will mostly verify trial correspondence such as reports and manage projects.

Work Schedule And Typical Hours

Work locations for these roles can be few and far between – often located in select areas of the country. This can require extensive commuting and longer hours at work. Working hours can vary, with overtime, weekend and holiday work days being fairly common. There will be many tight deadlines which will result in a fast-paced work environment among teams.

Positions in the field are also an option whereby you are based in a specific area and working at a study centre to compile relevant research. Short-term contracts of 6-12 months with a private company is another flexible work option, rather than becoming a full-time employee. A position with international companies will lead to arranging for clinical trials in other countries, such that overseas travel is required.

Growth Of The Job

The US Bureau of Labour Statistics (BLS) projects faster than average growth of around 18% for clinical and medical lab technicians.  Working as a clinical research associate leads to career opportunities in a growing sector – pharmaceutical research and development. There is a rise in employment potential of this sector due to companies looking for accurate ways to verify medical products prior to distribution, in order to safeguard against legal proceedings or irregularities.

Typical Employers

Clinical Research Associate positions are frequently offered by research-based medical drug and device companies like Phoenix Medical Systems, Medpace, etc. Clinical research institutes are also interested in recruiting for CRA positions, such as the Sarah Cannon Research Institute, focusing on providing advanced therapies for cancer patients, and the Walter Reed Army Institute of Research, which conducts basic and applied research in biomedical science.