When it comes to ensuring the best quality of a medical product, procedure, or drug, a clinical research associate job description tells you exactly what goes on behind the scene. People who take up this career role are saving lives through Good Clinical Practice.
A clinical research associate (CRA) is a professional who monitors the procedures in a clinical trial of biotechnological and pharmaceutical drugs, interventions, procedures, tools, and products before they are deployed to the market. The main duty of a clinical research associate seen in typical job descriptions is to ensure that clinical trials are done to match approved medical guidelines.
The minimum requirement for a clinical research associate is a Bachelor’s degree in Biological Science or related fields and a good knowledge of Good Clinical Practice and FDA regulation. Further qualifications can be gotten through hands-on experience in internships, school research laboratory experience, working in a pharmaceutical organization, etc. Further qualifications to boost a CV for clinical research associate jobs are taking online courses and earning certifications like Certified Clinical Research Associate (CCRA) from bodies like the Society of Clinical Research Associates (SOCRA).
Clinical research associates are fairly in high demand because of the importance of their jobs. For entry-level clinical research associates, the average salary is about $62,319 per year. Some popular organizations that employ clinical research associates are AstraZeneca and QuintilesIMS. Dive in to read more about the job description, duties, salary, and qualifications of clinical research associates.
Who Is A Clinical Research Associate?
Clinical research associates (CRAs) are healthcare professionals who monitor tests regarding the quality and efficacy of medical tools, products, interventions, or drugs before being approved for public use. They monitor these precautionary tests called clinical trials to ensure that medical, ethical, and safety regulations are met to prevent serious adverse effects and possible loss of lives that may occur if defective medical products or tools hit the market. CRAs are also known as clinical monitors or trial monitors.
They monitor clinical trials for companies about to release new or redefined medical products, contract research organizations, or government agencies. Some CRAs work freelance. Clinical research associates worldwide are generally expected to follow Good Clinical Practice, as quality, high-rated soft skills like integrity, confidentiality, and ethics are needed in their practice.
Clinical Research Associate Job Description
The main duty of clinical research associates is to monitor clinical trials to ensure compliance with clinical trial protocols. More of their duties typically include:
- Creating and documenting clinical trial protocols to be presented to the steering committee.
- Selecting a proper clinical trial site after proper evaluation that meets the standard requirements
- Ordering and tracking quality clinical trial materials
- Training clinicians on trial procedures
- Checking clinical sites activities during regular on-site visits
- Reviewing case report forms
- Ensuring compliance with medical guidelines, Good Clinical Practice, FDA regulations,
- Communicating and liaising with clinical research coordinators and regulatory authorities
- Making certain that the safety, wellbeing, and rights of human test subjects are enforced and protecting their information
- Protecting and verifying the scientific integrity of data collected
- Portray integrity by truthfully documenting and reporting adverse effects observed during clinical trials
- The salaries of clinical research associates are dependent on factors like skills level, qualification, location, organization, or freelance rates. A typical entry-level salary for CRAs is about $62,319 per year.
- For CRAs with more than 6 to 9 years of experience, the average salaries range between $83,342 to $123,739 per year.
- Based on location, clinical research associates in Canada earn about $99,905 on average. In Britain, the average salary for a clinical research associate is £36,190/ per annum. Australia has the average salary for a CRAs at AU$7615 per annum. For New Zealand, CRAs who are early in their career earn about NZ$62,719 per annum. In the US, the average salary for a CRA is about $97, 146 per annum.
- Companies like AstraZeneca pay their CRAs as high as $171, 522. DOCS provides an even higher salary rate of $253,153. Freelance clinical research associates are known to charge based on project requirements. Per project, freelance CRAs charge between $51,000 to $121,000.
Although clinical research associates’ salaries vary, they are quite similar in many locations and companies. Nevertheless, experience level a significant determinant in the range one might receive.
Unlike most jobs, clinical research associates do not work the typical 9 to 5 work hours. Because of the nature of their jobs, CRAs may be required to work extra hours for things like air travel, road trips to trial locations, or impromptu work-site visits. Weekends are also not excluded. The typical work locations for clinical research associates are sponsor locations and clinical trial sites. These locations could be situated in remote or long-distance places. Hence, CRAs typically need to be fit to travel, as they need to be physically available to supervise the clinical trials’ work-site. Some CRAs also work on more than one site at once.
How to Become A Clinical Research Associate
Gaining entry into a clinical research associate role requires both prior theoretical and practical experience in life sciences or related fields, monitoring, and administration. Practical knowledge in the pharmaceutical field is also an added advantage. The qualifications you need to become a clinical research associate include:
- A Bachelor’s degree in biological sciences, life science, health science, medical technology, clinical research, or related fields
- Experience through internships or student research associate engagements in laboratories for entry-level CRA jobs
- Certifications like Certified Clinical Research Associate (CCRA)
- Master’s and Ph.D. qualifications for expert-level CRA jobs that could bring higher pay
- Sound knowledge of Good Clinic Practice developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Basic computer skills like typing
- Proficiency with tools like MS Word, Excel, and Powerpoint
- Travel availability and fitness
- Driving skills and a valid driver’s license is an added advantage.
- Contract clinical research organizations (CCRO), which include big names such as Parexel International Corporation, Pharmaceutical Product Development, WuXi Apptec, Medpace Holdings, and so on
- Government agencies like clinicaltrials.gov
- Universities and research laboratories
Beyond a Bachelor’s degree in Biological Science or Life Sciences, clinical research associates usually need certifications to boost their qualifications. The two most recognized certification bodies for CRAs are:
- Association of Clinical Research Professionals (ACRP)
- Society of Clinical Research Associates (SOCRA).
Earning any of these certificates is not always a requirement in CRA jobs. However, it could put an applicant at advantage.