How to Be Clinical Investigator - Job Description, Skills, and Interview Questions

Feb 7, 2023 / 5 Minutes Read / By Albert

How to Become

Professional Organizations

FAQ

Links

The increasing demand for clinical investigators has created a surge in the number of qualified professionals in the field. As a result, clinical investigator salaries have risen significantly, making it an attractive career choice for those looking to pursue a stable and financially rewarding profession. The role of a clinical investigator is to assess the safety and efficacy of drugs, medical devices and treatments, as well as to conduct clinical trials and research studies.

Clinical investigators are also responsible for collecting, analyzing and reporting data, ensuring that their results meet the standards of the scientific community. With the ever advancing medical technology, clinical investigators are continually challenged to stay informed of the latest advances and develop new ways to study the data they collect. As such, clinical investigators must possess strong communication skills and have an aptitude for research.

Steps How to Become

Obtain a degree in a medical field such as medicine, nursing, or pharmacy. Clinical investigators must have an extensive background in the medical field in order to understand the nuances of clinical research and the ethical considerations involved.
Obtain experience in the medical field. Clinical investigators should ideally have a few years of experience in the medical field. This could include working as a doctor, nurse, or pharmacist. This experience will help give the investigator a better understanding of the clinical research process and the ethical considerations involved.
Obtain certification as a clinical investigator. In order to become certified, an individual must complete a course offered by the Association of Clinical Research Professionals (ACRP). This course covers topics such as study protocols, data analysis, and regulatory compliance.
Join a professional organization related to the clinical research field. Joining an organization such as the ACRP will give an investigator access to resources such as continuing education opportunities and networking events.
Pursue additional education and training related to the field of clinical research. Taking courses in epidemiology, biostatistics, and other related fields can help an investigator gain a better understanding of the clinical research process.
Find a job as a clinical investigator. Many pharmaceutical companies and research organizations hire clinical investigators to conduct clinical trials and research studies. It is important to network with individuals in the field in order to find job opportunities.

Becoming a skilled and competent clinical investigator requires a combination of essential knowledge and expertise. First, one must be well-versed in the scientific principles of the research field, such as biology, epidemiology, biostatistics, and pathology. a thorough understanding of the research process, including study design, protocol development and implementation, data collection, analysis and interpretation, and regulatory compliance is essential.

Furthermore, strong communication skills and the ability to collaborate with other stakeholders are also critical components of a successful clinical investigator. Finally, the ability to think critically and develop creative solutions to difficult challenges is invaluable in the field of clinical investigations. With these qualities and abilities, one can become a skilled and competent clinical investigator.

You may want to check Clinical Practice Manager, Clinical Lab Technician, and Clinical Trials Manager for alternative.

Job Description

Clinical Research Associate: Conducts research studies and clinical trials for pharmaceutical and medical device companies. Responsibilities include organizing and managing clinical trials, preparing and presenting study results, and providing technical support to research teams.
Clinical Trial Manager: Manages the implementation, coordination, and completion of clinical trials. Duties include designing protocols, recruiting and training personnel, monitoring trial progress, and ensuring compliance with regulations.
Clinical Data Manager: Analyzes and manages clinical trial data. Responsibilities include designing databases, verifying data accuracy, and preparing reports for sponsors and regulatory authorities.
Clinical Research Coordinator: Assists with the planning and execution of clinical studies. Responsibilities include recruiting study participants, maintaining databases, coordinating laboratory tests, and preparing reports.
Regulatory Affairs Specialist: Ensures compliance with government regulations. Duties include obtaining regulatory approvals, filing paperwork with government agencies, and responding to inquiries from regulatory authorities.
Clinical Lab Technician: Performs laboratory tests on samples collected during clinical trials. Responsibilities include processing specimens, analyzing results, and documenting findings.

Skills and Competencies to Have

Knowledge of clinical research principles, ethics, and regulatory requirements.
Ability to design clinical trials and interpret data.
Excellent written and verbal communication skills.
Problem solving, critical thinking, and organizational skills.
Ability to collaborate with other medical professionals and research teams.
Understanding of basic medical terminology and anatomy/physiology.
Proficiency in computer software and data analysis programs.
Ability to work independently and manage multiple projects simultaneously.
Knowledge of laboratory safety procedures and laboratory equipment.
Knowledge of Good Clinical Practice (GCP) guidelines and protocols.

Having an ability to think critically and analytically is one of the most important skills for a Clinical Investigator. Being able to identify causes and effects of diseases requires the ability to think deeply and critically, as well as the ability to draw conclusions from data. In addition to this, Clinical Investigators must be well-versed in many scientific fields such as biology, chemistry, and biochemistry.

They must also be able to apply this knowledge to clinical research and be able to effectively communicate their findings. Lastly, Clinical Investigators must have excellent organizational and management skills to be successful in their research. These skills allow them to manage time, resources, and personnel in order to carry out successful research studies.

Without these essential skills, Clinical Investigators would not be able to conduct accurate and reliable clinical research.

Clinical Nurse Leader, Clinical Quality Assurance Specialist, and Clinical Quality Auditor are related jobs you may like.

Frequent Interview Questions

What experience do you have in clinical research?
How do you stay up to date on changes in clinical research regulations?
What strategies do you use to ensure accuracy and excellence in data gathering?
Describe a recent project you completed that involved clinical research.
How do you ensure patient safety during clinical trials?
What challenges have you faced when conducting clinical research?
How do you collaborate effectively with other clinical investigators?
How do you handle difficult ethical dilemmas in clinical research?
Describe your approach to recruiting and training research participants.
What methods do you use to analyze and interpret data from clinical trials?

Common Tools in Industry

Clinical Trial Management System (CTMS). A software system used to manage the entire clinical trial process, from study design to reporting results. (eg: Oracle Clinical)
Electronic Data Capture (EDC). A software program used to electronically capture data during clinical trials. (eg: Medidata Rave)
Data Analysis Software. Software programs used to analyze clinical trial data. (eg: SPSS)
Clinical Trial Protocol Writing Software. Software used to write clinical trial protocols. (eg: Protocol Builder)
Regulatory Document Management Software. Software used to manage regulatory documents related to clinical trials. (eg: Veeva Vault)
Clinical Trial Budgeting Software. Software used to create and manage budgets for clinical trials. (eg: Costimator)
Patient Recruitment Software. Software used to recruit patients for clinical trials. (eg: Clinical Recruiter)
Research Site Management Software. Software used to manage research sites and clinicians involved in clinical trials. (eg: SiteHawk)

Professional Organizations to Know

American Society of Clinical Oncology (ASCO)
Association of Clinical Research Professionals (ACRP)
Society for Clinical Trials (SCT)
American College of Clinical Pharmacology (ACCP)
Pharmaceutical Research and Manufacturers of America (PhRMA)
International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
American Association of Pharmaceutical Scientists (AAPS)
American Society for Clinical Pathology (ASCP)
American Association for the Advancement of Science (AAAS)
Association of American Medical Colleges (AAMC)

We also have Clinical Data Programmer, Clinical Documentation Specialist, and Clinical Documentation Improvement Specialist jobs reports.

Common Important Terms

Clinical Trial. A type of research study that tests how well new medical approaches work in people.
Informed Consent. A process in which a person voluntarily agrees to take part in a clinical trial.
Protocol. A detailed plan that outlines how a clinical trial will be conducted.
Control Group. A group of participants in a clinical trial who do not receive the experimental intervention being tested in the trial.
Placebo. An inactive substance used in a clinical trial to compare the effects of the experimental intervention to the effects of not receiving it.
Randomization. A process used in clinical trials that assigns participants to either the experimental group or the control group at random.
Research Ethics. Standards that guide the ethical conduct of research with human participants.
Institutional Review Board (IRB). A committee of experts responsible for ensuring that research is conducted ethically and that the rights and welfare of research participants are protected.

Frequently Asked Questions

What is a Clinical Investigator?

A Clinical Investigator is a licensed healthcare professional responsible for conducting clinical trials and research studies.

What qualifications are required to become a Clinical Investigator?

Generally, a Clinical Investigator must have a medical degree and be licensed to practice medicine. In some cases, additional qualifications such as a PhD may be required.

What is the purpose of a Clinical Investigator?

The purpose of a Clinical Investigator is to conduct clinical trials and research studies in order to test the safety and efficacy of new drugs, treatments, and medical devices.

What are the responsibilities of a Clinical Investigator?

The responsibilities of a Clinical Investigator include designing, conducting, and monitoring clinical trials and research studies, collecting and analyzing data, and reporting results.

What is the average salary for a Clinical Investigator?

According to Payscale.com, the average salary for a Clinical Investigator is $93,706 per year.

Web Resources

Clinician Investigator Training Program - Mayo Clinic College of ... college.mayo.edu
Clinical Investigator Track - Internal Medicine Residency Program med.virginia.edu
Clinical Investigator Training Course | Center of cersi.umd.edu