NigCareers

Get to know about the duties, responsibilities, qualifications, and skills requirements of a clinical research associate. You can use our job description template in this article to produce your own. We also provide you with information about the salary you can earn as a clinical research associate.

 

Who is a Clinical Research Associate?

A clinical research associate (CRA) is medical research professional who serves as a point of contact for research sponsors and the clinics or hospitals that are conducting the research. CRAs run and oversee clinical trials as well as conduct medical research. They assess the efficacy of both new and old medications, as well as biomedical and healthcare technology, and determine if it is safe to release them onto the market for consumer use. To protect the safety of everyone involved, clinical research is a highly regulated sector that necessitates meticulous preparation and execution. By ensuring that protocols are appropriately followed and that data is accurately collected and evaluated, CRAs play an essential role in this process. They support study planning and execution, subject recruitment, follow-up on subjects, and data analysis. Clinical research associates (CRAs) are in charge of running research trials and making sure they’re properly done and by the law. To ensure that trials are carried out successfully and safely, they collaborate closely with patients, physicians, and other medical personnel. The primary duty of the CRA is to make sure that the protocol is followed and that patient safety is always put first.

The clinical research profession is dynamic, and new laws or patterns may have an impact on the job of a clinical research associate. Clinical research associates can read specialized journals, participate in conferences, or watch webinars offered by their companies or professional associations to stay current on these changes. Professionals working in clinical research must be aware of these updates to guarantee that all research participants are properly informed about the hazards associated with taking part in a trial. You need a Bachelor’s degree in life science, such as pharmacology, pharmacy, biochemistry, physiology, or toxicology, to work as a clinical research associate. Likewise, it might be in a medical science area like dentistry, nursing, or medicine. A relevant master’s degree in one of the aforementioned disciplines, typically with at least an upper second-class honours, is mostly preferred by some employers.

Additionally, it demands expertise in clinical laboratory work, pharmacy, nursing, and medical sales. To effectively use computerized processes, such as clinical trial management and electronic data capture tools to document and record information, the clinical research associate needs solid IT skills. Clinical research associates should possess strong verbal and written communication skills to establish productive working relationships with colleagues and trial centre employees. They must have strong analytical skills and a thorough awareness of scientific data management and gathering procedures. As a clinical research associate, you should be able to identify logistical issues and start relevant remedies if you want to succeed in the profession. You must be able to focus on details, be able to multitask and work well with a variety of team members.

 

Clinical Research Associate Job Description

Below are the clinical research associate job description examples you can use to develop your resume or write a job description for your employee. Employers can also use it to sieve out job seekers when choosing candidates for interviews.

The duties and responsibilities of a clinical research associate include the following:

• Draft and deliver trial protocols to the steering committee.
• Locate, assess, and set up trial locations, then close them after the experiment is finished.
• Offer training to staff at the site on the treatment areas, protocol requirements, appropriate source documentation, and case report form completion.
• Keep an eye on their health to ensure that patients are secure and comfortable during clinical trials.
• Get the patient’s consent by making them sign before starting treatment.
• Work with the research team to complete the study on time.
• Work with statisticians, study coordinators, nurses, and lab technicians to coordinate with other research team members.
• Test new medications on humans to establish their usefulness and safety.
• Create reports on findings for journals with peer review.
• Collect and evaluate data, including statistical analysis, data compilation, and report writing
• Conduct clinical trials for new medical tools or therapies in collaboration with a group of medical specialists.
• Obtain information about patients’ current health state from their medical records
• Communicate with the ethics committee to order to protect the rights, security, and welfare of test subjects.
• Order, track, and manage IP and trial materials.
• Find, assess, and establish clinical trial locations for performing research investigations
• Create, order, monitor, and control the clinical trial supplies
• Make sure all trial centres have enough supplies on hand Educate site employees about industry standards, protocol needs, and paperwork
• Coordinate with ethical committees and regulatory bodies to protect the rights, security, and well-being of study participants.
• Maintain the privacy of study participants’ personal information and data
• Work together with the study’s sponsors and the medical staff at the clinical trial location.
• Monitor research locations and activities to make sure they follow the study’s guidelines and relevant industry practices.
• Collect and verify case report forms, also known as data collection forms.
• Screen potential research participants by thorough medical record reviews, interviews, and follow-ups with healthcare practitioners.
• Work in concert with ethical committees to protect the rights, well-being, and safety of all study participants and research activities.
• Keep detailed records of all research activity, including consent forms, case reports, regulatory documents, and drug dispensing records.
• Complete new drug applications (NDAs), biological license applications, occasional manuscripts or publications, and final reports (BLAs).
• Ensure that clinical case data is properly transmitted to data management centres. Review case reports for any questions or issues and clarifies or obtain data changes as necessary.
• Oversee the hiring, training, goal-setting, and workload distribution of the research, technical, and administrative employees.
• Organize and direct the production of records and documents
• Follow the clinical trial as it progresses.
• Collect case report forms that have been completed at hospitals and clinics.
• Go over the clinical trial outcomes with the assistance of a medical statistician.
• Inform the study steering committee of the clinical trial’s findings.
• Finalize reports and maybe manuscripts for publication.
• Monitor and record the inventory and reconciliation of IP dispensing.
• Organize project meetings, conduct routine site visits, and write visit reports.
• Implement action plans for locations that aren’t performing up to par.
• Contact the appropriate regulatory bodies.
• Make sure that SOPs, local laws, ICH, and GCP standards are being followed.

 

Qualifications

• Bachelor’s degree in biological science or any relevant discipline.
• Over 2 years of working experience as a clinical research associate.
• Knowledge of the pharmaceutical industry, terminology, and practices.
• Knowledge of FDA regulations and their practical implementation.
• Excellent verbal and written communication skills.
• Proficiency in computer skills.
• Proficiency in Microsoft Office Word, Excel, and PowerPoint.
• Must be able to manage and prioritize workload effectively.
• Willingness to travel extensively and on short notice.
• Valid driver’s license, and reliable means of transportation.

 

Essential Skills

• Communication skills: The ability to communicate is essential for clinical research associates. This is because they usually interact with a wide range of individuals, including patients, other researchers, doctors, and industry representatives. It takes good communication to make sure that everyone is on the same page and that the research process goes well.
• Organizational skills: Due to the numerous activities they usually have to perform each day, clinical research associates essentially need to possess great organizational skills. Managing various calendars, tracking research data, and ensuring that all documents are in their proper locations are a few examples of this. You can accomplish your chores more quickly and accurately if you can maintain great organization.
• Attention to detail: Because clinical research associates regularly review and interpret data, attention to detail is an essential skill. They can verify if the data is thorough and precise with attention to detail skills. Clinical research associates that pay close attention to detail will be able to spot any inaccuracies in the data they review.
• Scientific knowledge: Clinical research associates must have a fundamental understanding of the scientific methodology and medical research. To make sure the data is accurate and the research is being carried out appropriately, they must be able to read and interpret the data and results of medical research. To make sure the research is done correctly, they also need to be able to understand the medical terminology used in it.
• Time management skills: Another skill that clinical research associates may find useful is time management skills. This is because they frequently have several duties to accomplish each day, all of which must be completed on time. They can do this to ensure they are producing high-quality work and assist them to satisfy the expectations of their employer.
• Problem-solving skills: Having the capacity to recognize and address problems is a problem-solving skill. When confronted with problems at work, such as when research doesn’t yield the intended findings or when equipment breaks down, clinical research associates regularly adopt problem-solving techniques. You may increase your productivity at work and guarantee that you complete projects on time by using your problem-solving skills. Clinical research associates must be able to think rapidly and come up with solutions that are acceptable to both the employer and the study participants.
• Protocols expertise: Clinical research associates must adhere to a set of guidelines called protocols to make sure research is carried out correctly. Protocols specify the methods for gathering, storing, and analyzing data as well as the safety measures to be performed when delivering treatments or medications. Clinical research associates can conduct studies safely and efficiently by being familiar with protocols.
• Investigative skills: Clinical research associates evaluate data and spot trends using their investigative skills. Investigative skills are also put to use while assessing study protocols, analyzing study findings, and offering suggestions for advancement. You should have the ability to sift through a lot of data as a clinical research associate and identify what’s crucial. To identify their root cause and suggest solutions, you might also need to look into any concerns that crop up throughout a trial.

 

How to Become a Clinical Research Associate

Step 1. Obtain a bachelor’s degree

Candidates for clinical research associate roles often need a bachelor’s degree in a discipline relevant to health sciences. Consider earning a degree in biological sciences, biomedical sciences, health sciences, medical technology, life science, or clinical research if you’re interested in working as a clinical research associate. You will have to enroll in classes in chemistry, biology, biochemistry, physiology, biostatistics, and other subfields of biosciences while pursuing an undergraduate degree. You can also choose to study medicine or pharmacy as an equivalent.

Step 2. Gain relevant work experience

Most firms prefer candidates with some expertise in the industry when hiring entry-level personnel for clinical research positions. By seeking part-time jobs in a lab or clinic, you can gain expertise. Take a look at internship programs offered by universities, medical schools, or hospitals. Additionally, you can discover fellowships that need assistance with their study or volunteer for chores and duties associated with clinical trials. Finally, consider applying for a position as a clinical research assistant or coordinator in pharmaceutical or clinical research businesses.

Step 3. Consider a master’s degree

Consider pursuing a master’s degree in a topic connected to health sciences if you believe you might want to work in management or supervision in the future. Many master’s degree programs are offered online, giving people who are employed full-time as clinical research associates more freedom. A candidate with a master’s degree may have greater employment opportunities, and prestigious pharmaceutical firms or clinical research organizations might favour hiring applicants with this degree. To obtain experience, think about taking part in clinical research studies now.

Step 4. Acquire certifications

You could pursue certification as a Certified Clinical Research Associate (CCRA), which the Association of Clinical Research Professionals offers, after gaining some experience as a clinical research associate. To be eligible, candidates must show that they carry out all necessary CCRA responsibilities while working independently of the investigating staff on behalf of a sponsor, such as a pharmaceutical firm or academic department. These responsibilities include checking the correctness of site records, guaranteeing complete reporting, and monitoring studies based on a clinical trial monitoring plan. Clinical research associates take part in continuing education to keep their certifications valid, though the volume of learning varies depending on the certifying body.

Step 5. Join professional organizations

Professional organizations such as The Association of Clinical Research Professionals (ACRP) can enable clinical research associates to connect with others professionals in the field and stay up to date on changes and developments in the industry. For people seeking to work in clinical research, the ACRP provides several services, such as online courses, webinars, and an online employment centre with job listings. Clinical research associates can earn certificates from the ACRP at various levels based on their level of expertise. For instance, whereas the professional level certification takes five years of experience, the associate level certification only requires two years of clinical research experience.

 

Where to Work as a Clinical Research Associate

Clinical research associates work in a variety of places such as hospitals, clinics, pharmaceutical companies, and research institutions. They may be full-time or part-time workers and their work hours may vary depending on the requirements of the research project. Some clinical research associates work on several projects at the same time, which can warrant frequent travelling. Clinical research associates usually work standard business hours, but they may often work during holidays, evenings, or weekends. This is to be able to attend meetings or to complete paperwork tasks. The work of a clinical research associate can be demanding, as they would have to often juggle several projects and ensure deadlines are met.

 

Clinical Research Associate Salary Scale

The salary scale of clinical research associates can significantly vary depending on factors such as level of education, years of experience, type of clinic or hospital, location, and additional qualifications. The salaries of clinical research associates in the US range from $69,250 to $187,200, with a median salary of $120,160 per year. A clinical research associate’s average salary is £42,500 per year. The salary typically starts at £35,673 and gets to about £56,450 per year. In Canada, these professionals earn an average of $66,905 per year. From $55,862 to $84,969 is the salary scale per year. A person working as a clinical research associate in Nigeria typically earns around 4,320,000 NGN per year. The salary ranges from 2,276,000 NGN to 6,452,000 NGN per year.

Health and Safety

Tags: Clinical Research Associate, Clinical Research Associate Job Description, Clinical Research Associate Qualifications, Clinical Research Associate Salary, Clinical Research Associate Skills, How to Become a Clinical Research Associate, Job Description, Who is a Clinical Research Associate