Clinical Research Scientist Job Description

What Is a Clinical Research Scientist?

A clinical research scientist is an expert in investigating the safety and effectiveness of new medical products. Clinical research scientists often spend much of their working hours in laboratories, where they carry out numerous experiments. They also work with pharmaceutical companies, physicians, and other healthcare professionals to develop new medications and treatments.

What Does a Clinical Research Scientist Do?

The Clinical Research Scientist is responsible for designing and conducting clinical research studies in compliance with the principles of good clinical practice (GCP) and applicable regulatory requirements. In addition to the scientific responsibilities highlighted above, this position also involves a high degree of administrative duties such as maintaining study files, preparing for and attending sponsor team meetings and serving as a liaison between site personnel and the sponsor team. This individual must be able to work independently under general supervision while managing others who provide support related to assigned projects or programs.

In addition to the scientific responsibilities highlighted above, this position also involves a high degree of administrative duties such as maintaining study files, preparing for and attending sponsor team meetings and serving as a liaison between site personnel and the sponsor team. This individual must be able to work independently under general supervision while managing others who provide support related to assigned projects or programs.

  1. Perform statistical analysis on medical records/research requirements using computer software (e.g., SAS).
  2. Manages statistical activities including planning, developing, testing, and implementing new procedures to support clinical trial conduct; identifying problems with data sources; evaluating proposed changes in procedures or resources; evaluating methods for improving efficiency, reliability, accuracy, and quality of clinical data.
  3. Conduct literature reviews to identify areas that need improvement.
  4. Process and document all trial data in compliance with Good Clinical Practice (GCP) guidelines as established by the US Food and Drug Administration (FDA), or International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
  5. Manage clinical trial data including the acquisition, validation, input, verification, analysis, storage/archiving, maintenance, retrieval throughout the study.
  6. Establish protocols to ensure all study sites are following protocol requirements.
  7. Ensure subject safety by monitoring adverse events/unanticipated problems during the course of a clinical trial; maybe designate an authorized safety representative.
  8. Prepare, review, and revisions of clinical protocols to meet changing requirements.
  9. Perform data entry; maintain data files; reconcile discrepancies; verify accuracy; prepare reports.
  10. Assist in the development and design of clinical trial documentation, including source documents (e.g., investigator brochure), protocol, case report forms (CRF's), specifications for labeling and packaging, and other supporting documents required by FDA or applicable regulatory agencies to support product marketing approvals; perform literature searches to obtain information used in writing procedures and reports.
  11. Monitor the timeliness of subject enrollment into study-specific sites.
  12. Identifies problems with data sources such as missing or erroneous data, assesses consequences on statistical analysis, and develops corrective action plans.
  13. Serve as a statistical consultant to project team members (e.g., clinical research associates, medical monitors, study managers).
  14. May be required to lead and/or participate in data review meetings.
  15. May coordinate or lead the development of statistical analysis plans, tables, listings, and figures for clinical study reports.
  16. Assesses adequacy of the trial design with respect to meeting predetermined objectives and timelines; assists with developing recommendations for protocol amendments as needed.
  17. Writes sections of clinical study reports, such as the Introduction, Methodology, Results, and Discussion; may also write accompanying documentation (e.g., protocols, informed consent forms).
  18. Presents scientific findings at internal and external meetings; may author or co-author abstracts, manuscripts for publication.
  19. May provide guidance to less experienced clinical research staff.
  20. Maintains knowledge of applicable regulations governing clinical trials (e.g., ICH GCP, 21 CFR Part 11, Good Laboratory Practice (GLP), FDA Amendments Act of 2007).

Clinical research scientists investigate the effects of new medical treatments by testing them on laboratory animals before they are tested on human subjects. After a drug has been approved, clinical research scientists continue to monitor its safety and effectiveness in order to make sure that more advanced or powerful drugs do not have dangerous side effects.

In addition, clinical research scientists monitor consumer products such as cosmetics and tobacco for potential health hazards. They also advise governmental agencies on how to deal with emergencies involving chemical spills and other toxic substances.

Most clinical research scientists specialize in a specific area of medicine, such as diabetes or heart disease. Medical researchers may specialize further within this area - for example, a cardiologist who specializes in the research of heart disease.

Some clinical research scientists work with medical technicians to conduct experiments on human subjects in a laboratory setting, such as testing the effects of new drugs or cosmetics. Clinical researchers must always be aware of Good Laboratory Practices (GLP) and follow standard operating procedures (SOPs). After conducting experiments, they are responsible for recording all data generated by the studies into computer databases. They must also store this large amount of data in an accurate and organized manner to ensure that it can be easily accessed when necessary. Medical Researchers often communicate their findings to other members of the scientific community through published articles or oral presentations at conferences or seminars.

Clinical research scientists spend most of their time indoors working regular business hours on weekdays. During the evening, they may attend scientific meetings or work on experiments in a laboratory setting. Some weekend work is occasionally required, but it is generally less than what is demanded of other research scientists.

How Do I Become a Clinical Research Scientist?

There are several ways to become a clinical research scientist. One way is to earn a bachelor's in biology, chemistry, or another scientific discipline. Then a master's degree in biological science or biomedical engineering, and a Ph.D. may be required for some entry-level research scientist positions. You will need to have excellent written and oral communication skills as well as strong organizational skills. Being familiar with computer databases is important too, as you will need to store and search large amounts of data related to your experiments.

In the US, clinical research scientists must pass the Clinical Laboratory Improvement Amendments (CLIA) exam given by the College of American Pathologists (CAP). According to CAP, this exam tests the knowledge necessary "to ensure quality laboratory medicine" and ensures that all lab professionals employ safe practices at all times.

Volunteering or working in a hospital laboratory may give you some experience and knowledge in the field of clinical research. It is also important to be up-to-date on the latest medical technologies and treatments. Networking with other clinical research scientists is a great way to learn more about the field, as well as possible career opportunities.

Many professional organizations offer continuing education courses and workshops for clinical research scientists. The Association for Clinical Research Professionals (ACRP) is one such organization that provides online and in-person educational opportunities on various topics, such as good clinical practice (GCP), regulatory updates, and scientific writing.

Clinical research scientist jobs are typically posted on job boards such as Indeed.com, Monster.com, or BioSpace.com.

The clinical research scientist's job description entails working with pharmaceutical and medical device companies, as well as contract research organizations (CROs), to design, plan, and execute clinical studies that test the safety and efficacy of new drugs and treatments. They work with other medical researchers to develop hypotheses for clinical studies, design experiments, collect and analyze data, and write papers on their findings.

Clinical research scientists must have a strong scientific background, as well as knowledge of Good Laboratory Practices (GLP) and standard operating procedures (SOPs). They must be able to work independently in a laboratory setting as well as be able to lead a team of technicians. Excellent communication skills are also necessary, as they often need to present their findings to others in the scientific community.

Clinical research scientists typically have a bachelor's degree in a scientific discipline, although a master's degree and/or a Ph.D. may be necessary for some positions. They must also pass the Clinical Laboratory Improvement Amendments (CLIA) exam administered by the College of American Pathologists (CAP). In order to keep up with the latest medical technologies and treatments, they should also stay abreast of the latest industry news and developments. Networking with other clinical research scientists is an excellent way to learn more about the field.

The job outlook for clinical research scientists is very good across the board, according to the US Bureau of Labor Statistics. The occupation is expected to grow 26% between 2014 and 2024, much faster than average. An aging population that requires more medical care will drive demand for new treatments, which in turn will create jobs for qualified clinical research scientists.

What Kind of Education Do I Need To Be a Clinical Research Scientist?

In order to become a clinical research scientist, you need at least a bachelor's degree in a scientific discipline. However, many positions may require a master's degree and/or a Ph.D. A few universities offer graduate-level programs specifically in clinical research science, but many students obtain this knowledge by completing a traditional biology or chemistry degree and then specializing in clinical research as they pursue their careers.

In order to work in the United States, you must pass the Clinical Laboratory Improvement Amendments (CLIA) exam administered by the College of American Pathologists (CAP). This exam tests your knowledge of various aspects of laboratory medicine and ensures that all lab professionals employ safe practices at all times.

What Are Some Typical Duties of a Clinical Research Scientist?

Clinical research scientists are responsible for designing, planning, and executing clinical studies. They work with other medical researchers to develop hypotheses for clinical studies, design experiments, collect and analyze data, and write papers on their findings.

In order to do this, they must have a strong scientific background as well as knowledge of Good Laboratory Practices (GLP) and standard operating procedures (SOPs). They must also be able to work independently in a laboratory setting as well as lead a team of technicians. Excellent communication skills are also necessary, as they often need to present their findings to others in the scientific community.

What Is the Job Outlook for Clinical Research Scientists

According to the US Bureau of Labor Statistics, the job outlook for clinical research scientists is very good across the board. The occupation is expected to grow 26% between 2014 and 2024, much faster than average. An aging population that requires more medical care will drive demand for new treatments, which in turn will create jobs for qualified clinical research scientists.

Why Should I Consider a Career as a Clinical Research Scientist?

There are many reasons to consider a career as a clinical research scientist:

It's scientifically challenging:

As a clinical research scientist, you'll be on the front lines of the battle against the disease. You will design, plan, and execute experiments as well as analyze data to discover ways to improve human health.

There's a high demand for qualified candidates:

Thanks to an aging population that is living longer than ever before, there is a greater need for medical care. And as more treatments are developed through clinical research, there will be no shortage of jobs in this field.

A career as a clinical research scientist requires strong scientific skills:

In order to do your job effectively, you should have a strong background in both biology and chemistry. These areas provide the foundation upon which your knowledge of clinical research can grow throughout your career. You must understand how experiments work and how to test hypotheses without bias or error so that accurate data can be collected.

You have the potential to make a real difference in people's lives:

As a clinical research scientist, you may help develop new treatments that improve or save the lives of millions of people. Your work could one day lead to a cure for cancer or some other devastating disease.

Clinical research scientists are in high demand:

With a job outlook of 26%, clinical research scientists are in high demand. This growth is due to an aging population, increased life expectancy, and the need for more medical treatments.

The median annual salary for clinical research scientists is $73,550:

This means that half of all clinical research scientists earn more than this amount and half earn less.

You have the opportunity to make a real difference in people's lives:

As a clinical research scientist, you may help develop new treatments that improve or save the lives of millions of people. Your work could one day lead to a cure for cancer or some other devastating disease.

So, if you're looking for an exciting and challenging career that has the potential to make a real difference in people's lives, consider becoming a clinical research scientist. It's an occupation that is growing rapidly and is in high demand, and you will have the opportunity to do important work that can benefit society as a whole.

What Can I Expect If I Want a Medical Degree?

If you want to become a clinical research scientist, you will need to have a medical degree. This is the typical route to this career field, and it will provide you with the training you need to understand how diseases work and how to test treatments. You can expect to complete a four-year undergraduate degree, followed by four years of medical school. After that, you will need to do a residency program, which can last anywhere from three to seven years. So, if you're looking to become a clinical research scientist, be prepared for a long journey!

What Are Some Common Courses in Medical School?

Here are some common courses you can expect to find in medical school:

  • Anatomy: This course will teach you about the various parts of the body and how they work together.
  • Biochemistry: In this course, you'll study organic chemistry as it pertains to biological systems. You will also learn about biochemical processes that underlie life and disease.
  • Physiology: This course focuses on how the human body works. Through these lessons, you can learn about bodily functions such as digestion, reproduction, vision, immunity, and more.

Other courses may include pathology, pharmacology, behavioral sciences electives, and clinical experience rotations.

What If I Want A Doctorate?

If you want to pursue a career in clinical research science, you may also consider getting a doctorate. This will allow you to conduct your own research and become a leader in the field. A Ph.D. in clinical research can be obtained from many universities, and it typically takes four years to complete.

What Are Some Common Courses in a Ph.D. Program?

Here are some common courses you can expect to find in a Ph.D. program in clinical research:

  • Research Methods: In this course, you will learn how to design and execute rigorous scientific studies that produce accurate results.
  • Clinical Trials: This course will teach you about the design, implementation, and assessment of clinical trials.
  • Bioethics: In this course, you will learn about the ethical principles that guide the conduct of biomedical research.
  • Statistics: This course will teach you how to analyze data and draw accurate conclusions from it.
  • Other courses may include epidemiology, health services research, and clinical informatics.

So, if you're looking to become a clinical research scientist, be prepared for a long journey! The path to this career requires a medical degree, and even then you may want to consider getting a Ph.D. so you can conduct your own research. But the work is well worth it: You'll have the opportunity to help develop new treatments that improve or save the lives of millions of people. What could be more rewarding than that?

Do I Need To Be Licensed?

In order to work as a clinical research scientist, you may need to be licensed in your state. The requirements for licensure vary by state, so it's important to check with your local licensing board to find out what is required. Generally, you will need to complete an exam and meet certain educational and experience requirements. You may also need to pass a criminal background check.

What Are Some Common Job Titles?

Clinical research scientists can have many different job titles, depending on their area of specialization. Some common titles include:

  • Clinical Researcher
  • Clinical Research Coordinator
  • Clinical Research Manager
  • Clinical Trial Manager
  • Clinical Research Director
  • Medical Science Liaison

Where Can I Work?

Clinical research scientists can work in a variety of settings, including hospitals, universities, pharmaceutical companies, and biotech firms. They may also work for government agencies such as the National Institutes of Health (NIH) or the Centers for Disease Control and Prevention (CDC).

How Much Does a Clinical Research Scientist Make?

The average salary for a clinical research scientist in 2016 was $66,352. It is important to note that salaries vary based on where you live and work; in general, cities pay more than rural areas. For example, the US Bureau of Labor Statistics estimates that clinical research scientists in San Francisco earn an average annual salary of $104,180 to start out, while those working in Grand Rapids earn just $62,970 to begin their careers.

What Are the Challenges of a Clinical Research Scientist?

The most important challenge for clinical research scientists is to always maintain the highest level of quality and safety in their work. This includes adhering to Good Laboratory Practices (GLP) and following standard operating procedures (SOPs). Clinical research scientists must also be able to communicate effectively with other members of the team, as well as regulatory agencies and the scientific community. They must be organized and able to manage large amounts of data. Maintaining up-to-date knowledge of the latest scientific developments is also essential.

The job of a clinical research scientist can be challenging but also very rewarding. It is important to have excellent organizational skills to manage large amounts of data with many different people involved. It is also important to be able to communicate effectively with all parties in the scientific community. Because this job is highly multifaceted, it can be difficult to find qualified personnel that is up-to-date with the latest developments in science and medicine.

Research scientists often work long hours with little time for leisure activities outside of work. Those who carry out animal studies may also be exposed to health risks in the lab, such as chemicals or disease outbreaks. This is one reason why research scientists must always adhere to Good Laboratory Practices (GLP) when conducting experiments in a laboratory environment.

There are several challenges faced by clinical research scientists but the most important challenge is maintaining the highest level of quality and safety. Maintaining up-to-date knowledge of the latest scientific developments is also essential.

To sum up

The job of a clinical research scientist can be rewarding and challenging. The most important challenge faced by clinical research scientists is maintaining the highest level of quality and safety in their work. They must also be able to communicate effectively with other members of the team, as well as regulatory agencies and the scientific community. Additionally, they must be able to manage large amounts of data. Maintaining up-to-date knowledge of the latest scientific developments is essential for this profession.