How to Be Science Clinical Research Associate - Job Description, Skills, and Interview Questions

Dec 4, 2020 / 6 Minutes Read / By Albert

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A Clinical Research Associate (CRA) is a professional who plays an important role in the clinical research process. The primary responsibility of a CRA is to ensure that all activities related to a clinical trial are conducted in accordance with good clinical practice, regulatory guidelines, and the study protocol. As a result, CRAs are essential for the successful completion of clinical trials, and can have a significant impact on public health and the development of new treatments and cures.

With their detailed knowledge of the clinical research process, CRAs can help to ensure the accuracy of data, minimize risks to participants, and provide valuable insight into the effectiveness of the trial. Furthermore, CRAs often act as liaisons between sponsors, sites, and study personnel, facilitating communication and resolving issues that may arise.

Steps How to Become

Earn a Bachelors Degree. The first step to becoming a Science Clinical Research Associate is to earn a bachelors degree in a science-related field. Common majors include biology, chemistry, biochemistry, or a related field.
Gain Lab Experience. Clinical research associates should have experience working in a laboratory setting. You can gain experience during your undergraduate career by working in a lab as an intern or research assistant.
Pursue Certification. Although certification is not necessary to become a Science Clinical Research Associate, it can give you an advantage when applying for jobs. The National Institute of Health offers a Certified Clinical Research Associate (CCRA) program that can provide you with the skills and knowledge needed for the role.
Find an Entry-Level Position. Once you have the necessary education and experience, you can apply for entry-level positions as a clinical research associate. Many pharmaceutical companies offer such positions, so you should be able to find one with some effort.
Stay Up-to-Date on Regulations. As a Science Clinical Research Associate, you must stay up-to-date on all federal and state regulations related to clinical trials and research. This includes understanding the ethical principles of conducting clinical trials and adhering to all applicable laws and regulations.
Develop Your Skills. As you gain more experience in the field, you should also develop your skills in data collection and analysis, project management, and communication. These skills will help you become a more effective Science Clinical Research Associate.

Clinical research associates (CRAs) play a critical role in the development of treatments and medications. To remain capable and up-to-date, CRAs must stay informed on the latest trends and developments in the medical field. This can be accomplished through attending relevant conferences, reading scientific journals, and participating in continuing education courses.

CRAs must actively participate in clinical trials and stay informed of changes in regulations and guidelines. By staying informed, CRAs can ensure that the research they are conducting is conducted in a safe and ethical manner, while also providing quality healthcare to those who need it.

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Job Description

Develops and maintains relationships with clinical investigators and research sites.
Develops and manage clinical trial budgets.
Reviews and interprets clinical trial protocols, ICF/CRFs, and other related documents.
Monitors data collection, query resolution, and data entry for accuracy and completeness.
Performs regular site visits to ensure study compliance with protocol, ICH/GCP, and other applicable regulations.
Ensures timely reporting of safety events and other relevant information to internal and external stakeholders.
Provides guidance and training to research sites on protocol and study procedures.
Assists in the preparation and submission of study documents to regulatory authorities.
Reviews final study data for accuracy and completeness prior to submission to regulatory authorities.
Assists in the development of investigator brochures and other study materials.

Skills and Competencies to Have

Knowledge of FDA regulations and Good Clinical Practice (GCP) guidelines
Ability to interpret and analyze clinical data
Excellent organizational and project management skills
Strong written and verbal communication skills
Ability to work independently and in teams
Proficient in computer applications such as Microsoft Office
Ability to prioritize tasks and manage multiple projects
Understanding of clinical trial process from protocol development to database lock
Excellent problem-solving and critical thinking skills
Ability to maintain accurate records and manage documents
Knowledge of medical terminology and clinical research protocols
Ability to review and monitor safety data for adverse events

The most important skill for a Clinical Research Associate is the ability to effectively communicate. Effective communication is critical to ensure that the research project is completed on time, within budget, and with minimal errors. This requires a person to be able to clearly explain their ideas to other members of the research team and to be able to listen to the ideas of others.

a Clinical Research Associate must be able to organize and prioritize tasks in order to ensure that the study is completed according to schedule. This requires attention to detail and strong organizational skills. Finally, a Clinical Research Associate must have a good understanding of the ethical and regulatory requirements for conducting clinical research in order to ensure that the research is conducted safely and ethically.

All of these skills are essential for a successful Clinical Research Associate.

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Frequent Interview Questions

What experience do you have working in clinical research?
What specific challenges have you faced in clinical research?
What skills do you possess that make you an ideal candidate for a Clinical Research Associate position?
How would you ensure compliance with SOPs and GCPs?
How do you stay up to date on the latest developments in clinical research?
Describe an experience you had working with a cross-functional team.
What strategies do you use to effectively manage multiple projects at once?
How would you manage a difficult or challenging sponsor relationship?
How do you ensure accurate and timely data entry, analysis, and reporting?
Describe your experience with clinical trial documentation and reports.

Common Tools in Industry

Microsoft Excel. An electronic spreadsheet program used to store, organize, and analyze data. (e. g. Creating pivot tables to track patient outcomes)
ClinicalTrials. gov Database. A public registry and results database of clinical studies of human participants conducted around the world. (e. g. Searching for relevant clinical trials)
Clinical Research Management Systems (CRMs). Software programs used to manage the clinical trial process, from protocol design to data analysis. (e. g. Monitoring patient data and providing real-time reporting)
Clinical Data Management Systems (CDMS). Software programs used to collect, store, and analyze clinical trial data. (e. g. Automatically transferring patient data from CRMs to CDMS)
Electronic Data Capture (EDC). Software programs used to securely collect and store clinical trial data electronically. (e. g. Creating an EDC system for collecting patient data)
Regulatory Affairs Software. Software programs used to manage the regulatory submission process for clinical trials. (e. g. Ensuring compliance with regulatory requirements)
Monitoring Software. Software programs used to monitor clinical trials in real-time to detect issues or adverse events. (e. g. Setting up automated alert notifications for potential issues)
Statistical Analysis Software. Software programs used to analyze data from clinical trials to draw conclusions or identify trends. (e. g. Running statistical tests to compare patient outcomes)

Professional Organizations to Know

Association of Clinical Research Professionals (ACRP)
Society for Clinical Research Associates (SOCRA)
Clinical Research Professionals Network (CRPN)
American Society for Clinical Laboratory Science (ASCLS)
Association of Clinical Research Organizations (ACRO)
National Organization for Clinical Research Professionals (NOCRP)
International Society for Pharmaceutical Engineering (ISPE)
Drug Information Association (DIA)
Association of Regulatory and Clinical Scientists (ARCS)
Regulatory Affairs Professionals Society (RAPS)

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Common Important Terms

Protocol. A detailed plan or set of instructions for conducting a clinical trial.
Institutional Review Board (IRB). An independent committee that reviews and approves proposed clinical trials to ensure that the rights and welfare of participants are protected.
Clinical Study Report (CSR). A document produced at the completion of a clinical trial that summarizes the research findings.
Investigational Drug. A drug that is not approved by the FDA but is being studied in a clinical trial.
Informed Consent. A document that explains the risks and benefits of participating in a clinical trial and must be signed by the participant before they can take part in the study.
Adverse Event. An unexpected and unwanted reaction to an investigational drug or medical device during a clinical trial.
Sponsor. An individual, company, or organization that has financial responsibility for the design, conduct, and funding of a clinical trial.
Investigator. A doctor or other healthcare professional who is responsible for the conduct of the clinical trial at a specific site.

Frequently Asked Questions

What is a Clinical Research Associate (CRA)?

A Clinical Research Associate (CRA) is a professional responsible for managing the clinical research process of a medical study, including monitoring and tracking the progress of the study, ensuring compliance with applicable regulations, and reporting results.

What qualifications do you need to be a CRA?

To become a CRA, you must have a bachelors degree in a scientific or health care-related field, such as nursing, pharmacology, or biology. You should also possess strong organizational skills, attention to detail, and communication skills.

What are the primary responsibilities of a CRA?

The primary responsibilities of a CRA include developing and executing study protocols, recruiting and training research staff, providing study-related support and guidance to investigators, and ensuring compliance with established regulations.

How much does a CRA earn on average?

According to PayScale.com, the median annual salary for a CRA is $60,553. Salaries can vary depending on experience, location, and other factors.

What professional organizations are available to CRAs?

Professional organizations available to CRAs include the Society of Clinical Research Associates (SOCRA), the Association of Clinical Research Professionals (ACRP), and the Clinical Research Professional Certification Council (CRPCC).

Web Resources

Clinical Research Science Program - North Carolina Central www.nccu.edu
Clinical Research Associate | NC State Online and Distance online-distance.ncsu.edu
Clinical Research Sciences Certificate - North Carolina Central www.nccu.edu