PI / Principal Investigator

Term from Clinical Trials industry explained for recruiters

A Principal Investigator (PI) is the lead researcher who oversees clinical trials and medical research studies. Think of them as the project manager and scientific leader who is responsible for everything that happens in a clinical trial. They make sure the research is done correctly, safely, and follows all the rules. When you see "PI" in a resume or job description, it usually means either someone who has worked with Principal Investigators or has been one themselves. This role is essential in hospitals, research centers, pharmaceutical companies, and medical device companies that run clinical trials to test new medicines or treatments.

Examples in Resumes

Supported PI in managing Phase III clinical trials for diabetes medication

Served as Principal Investigator for 5 successful oncology studies

Coordinated between PI and study staff for data collection and patient monitoring

Typical job title: "Principal Investigators"

Also try searching for:

Clinical Research Principal Investigator Research Director Lead Investigator Clinical Trial PI Medical Research Lead Study Principal Investigator

Example Interview Questions

Senior Level Questions

Q: How do you handle serious adverse events in a clinical trial?

Expected Answer: Should explain their experience with patient safety protocols, reporting procedures, and decision-making process for continuing or stopping a trial. Should mention working with ethics committees and sponsors.

Q: Describe your experience managing multiple clinical trials simultaneously.

Expected Answer: Should discuss organizational strategies, team delegation, priority management, and maintaining compliance across multiple studies while ensuring quality and safety.

Mid Level Questions

Q: What steps do you take to ensure protocol compliance in a clinical trial?

Expected Answer: Should describe monitoring procedures, staff training, documentation practices, and quality control measures they've implemented.

Q: How do you handle conflicts between study requirements and patient needs?

Expected Answer: Should discuss balancing research goals with patient welfare, protocol modifications when necessary, and communication with sponsors and ethics committees.

Junior Level Questions

Q: What are the basic components of a clinical trial protocol?

Expected Answer: Should be able to list key elements like study objectives, inclusion/exclusion criteria, treatment plan, and safety monitoring procedures.

Q: What is informed consent and why is it important?

Expected Answer: Should explain the process of obtaining patient agreement to participate in research, including explaining risks and benefits, and maintaining documentation.

Experience Level Indicators

Junior (0-3 years)

  • Understanding of clinical trial protocols
  • Basic knowledge of regulatory requirements
  • Experience with data collection
  • Ability to work with study coordinators

Mid (3-7 years)

  • Management of small to medium trials
  • Protocol development experience
  • Team supervision abilities
  • Budget management experience

Senior (7+ years)

  • Multiple trial management
  • Strategic planning expertise
  • Grant writing experience
  • Leadership of large research teams

Red Flags to Watch For

  • No experience with regulatory compliance or IRB processes
  • Limited understanding of Good Clinical Practice (GCP)
  • Poor track record of completing studies on time
  • Lack of experience managing research budgets
  • History of protocol violations or audit findings