Clinical Research Coordinator

90+ Clinical Research Coordinator Interview Questions and Answers

Updated 2 Jul 2025
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4d ago

Q. If a subject is between 2 and 12 years old, who is responsible for obtaining informed consent?

Ans.

The parent or legal guardian is responsible for obtaining informed consent for subjects aged 2 to 12 years old.

  • The parent or legal guardian should be fully informed about the study and its risks and benefits.

  • The parent or legal guardian should be given ample time to ask questions and make an informed decision.

  • The informed consent process should be documented thoroughly.

  • Assent should also be obtained from the child, if possible.

  • If the child is unable to provide assent, the par...read more

1d ago

Q. What should you do if a deep freezer is damaged or loses power?

Ans.

Notify the appropriate personnel immediately and follow the standard operating procedure for handling damaged or non-functional equipment.

  • Check the temperature of the freezer and record it.

  • Transfer the contents of the freezer to a backup freezer or a temporary storage unit.

  • Notify the supervisor or the maintenance team immediately.

  • Follow the standard operating procedure for handling damaged or non-functional equipment.

  • Document the incident and the actions taken in the appropri...read more

Clinical Research Coordinator Interview Questions and Answers for Freshers

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3d ago

Q. 3. What is Clinical Research 4. Responsibilities of Clinical Research Coordinator

Ans.

Clinical research involves studying the safety and effectiveness of medical treatments and interventions on human subjects.

  • Designing and implementing clinical trials

  • Recruiting and screening potential study participants

  • Collecting and analyzing data

  • Ensuring compliance with ethical and regulatory guidelines

  • Communicating with study sponsors and investigators

  • Managing study budgets and timelines

5d ago

Q. What is the difference between LAR and IW?

Ans.

LAR stands for Last Available Record while IW stands for Interim Withdrawal.

  • LAR refers to the last data point collected before a participant drops out of a study.

  • IW refers to a participant withdrawing from a study before its completion.

  • LAR is used in statistical analysis while IW is used in safety analysis.

  • LAR is also known as LLOQ (Last Locus of Observation Quantifiable).

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Asked in Leszarians

5d ago

Q. Which document is signed first in a clinical trial?

Ans.

The first document signed in a clinical trial is the Informed Consent Form (ICF), ensuring participant understanding and agreement.

  • The Informed Consent Form (ICF) is crucial for participant autonomy.

  • It outlines the study's purpose, procedures, risks, and benefits.

  • Participants must understand their rights, including the right to withdraw.

  • Example: A participant reads the ICF before agreeing to join a drug trial.

6d ago

Q. What AEs and SAEs are you facing in your present clinical trial?

Ans.

I am not currently involved in a clinical trial, so I cannot provide information on AE's and SAE's.

  • Not involved in a clinical trial at present

  • Cannot provide information on AE's and SAE's

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Q. What are all the phases,what is important of doing clinical research

Ans.

Clinical research has four phases, each with a specific purpose and goal.

  • Phase 1: Safety and dosage testing

  • Phase 2: Efficacy and side effect testing

  • Phase 3: Large-scale testing for safety and efficacy

  • Phase 4: Post-market surveillance

  • Clinical research is important for developing new treatments and improving patient outcomes

  • It helps to ensure the safety and efficacy of new treatments before they are made available to the public

  • It also helps to advance medical knowledge and impr...read more

2d ago

Q. What is pharmacodynamics or pharmacokinetics

Ans.

Pharmacodynamics is the study of how drugs affect the body, while pharmacokinetics is the study of how the body affects drugs.

  • Pharmacodynamics focuses on the drug's mechanism of action and its effects on the body

  • Pharmacokinetics focuses on how the body absorbs, distributes, metabolizes, and excretes drugs

  • Understanding pharmacodynamics and pharmacokinetics is important in determining the appropriate dosage and potential side effects of a drug

  • Examples of pharmacodynamics includ...read more

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Q. Tell me about yourself. What is clinical research? What is ICH GCP? ….etc

Ans.

Clinical research coordinator with knowledge of ICH GCP guidelines and experience in managing clinical trials.

  • Clinical research involves conducting studies to evaluate the safety and efficacy of new drugs, devices, or treatments.

  • ICH GCP (International Conference on Harmonisation Good Clinical Practice) is a set of guidelines that ensure ethical and scientific quality standards are met in clinical trials.

  • As a clinical research coordinator, I have experience in managing clinica...read more

1d ago

Q. Describe the entire process of conducting a clinical trial.

Ans.

Conducting a clinical trial involves planning, executing, monitoring, and analyzing research to evaluate new treatments or interventions.

  • 1. Study Design: Define objectives, choose between randomized controlled trials or observational studies.

  • 2. Protocol Development: Create a detailed plan outlining methodology, participant criteria, and endpoints.

  • 3. Regulatory Approval: Submit the protocol to ethics committees and regulatory bodies for approval.

  • 4. Recruitment: Identify and en...read more

Q. What tests are needed to determine the cholesterol level in the human body?

Ans.

Blood tests like lipid panel, fasting lipid profile, and total cholesterol test are needed to know the cholesterol level in the human body.

  • Lipid panel test measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides in the blood.

  • Fasting lipid profile requires fasting for 9-12 hours before the test to get accurate results.

  • Total cholesterol test measures the total amount of cholesterol in the blood, including LDL, HDL, and VLDL cholesterol.

  • Other tests like A...read more

Q. What do you know about clinical research?

Ans.

Clinical research involves conducting studies to evaluate the safety and effectiveness of medical treatments and interventions.

  • Clinical research is conducted to gather data and evidence to support the development of new treatments and interventions.

  • It involves recruiting participants, collecting data, and analyzing results.

  • Clinical research is regulated by ethical and legal guidelines to ensure the safety and well-being of participants.

  • Examples of clinical research include dr...read more

Q. Which phases of clinical trials have you worked on?

Ans.

I have worked in all phases of clinical trials.

  • Phase 1: I have experience in conducting early-stage trials to evaluate the safety and dosage of new drugs.

  • Phase 2: I have worked on trials that assess the effectiveness of the drug and gather more safety data.

  • Phase 3: I have been involved in large-scale trials to confirm the drug's effectiveness, monitor side effects, and compare it to existing treatments.

  • Phase 4: I have participated in post-marketing studies to gather additiona...read more

Asked in Leszarians

2d ago

Q. Is a Phase 4 trial mandatory for all studies?

Ans.

Phase 4 trials are not mandatory for all studies, they are conducted after a drug or treatment has been approved and marketed.

  • Phase 4 trials are post-marketing studies conducted to monitor the safety and effectiveness of a drug or treatment in real-world settings.

  • These trials are not mandatory for all studies, but are often required by regulatory agencies to gather additional data on long-term safety and efficacy.

  • Phase 4 trials can also investigate new uses for approved drugs...read more

6d ago

Q. Define the terms AE, SAE, ADR, and SADR.

Ans.

AE stands for Adverse Event, SAE stands for Serious Adverse Event, ADR stands for Adverse Drug Reaction, and SADR stands for Serious Adverse Drug Reaction.

  • AE refers to any unfavorable medical occurrence in a patient during or after the use of a drug or medical device.

  • SAE refers to an AE that results in death, is life-threatening, requires hospitalization, causes significant disability, or requires intervention to prevent harm.

  • ADR refers to any response to a drug that is noxio...read more

6d ago

Q. What is informed consent?

Ans.

Informed consent is the process of obtaining permission from a patient or participant after providing them with all relevant information about a medical procedure or research study.

  • Informed consent involves providing detailed information about the purpose, risks, benefits, and alternatives of a medical procedure or research study.

  • The patient or participant must have the capacity to understand the information provided and make an informed decision.

  • Informed consent should be vo...read more

Q. Do you have experience using the Sugam Portal to notify SAEs?

Ans.

I have utilized the Sugam Portal for efficient SAE notifications in clinical trials, ensuring compliance and timely reporting.

  • Familiar with the Sugam Portal interface for SAE reporting.

  • Experience in entering detailed SAE information, including patient data and event descriptions.

  • Ensured timely submission of SAEs within regulatory timelines, enhancing patient safety.

  • Collaborated with the clinical team to gather necessary documentation for SAE notifications.

  • Utilized the portal'...read more

1d ago

Q. Describe a bioequivalence or bioavailability study.

Ans.

Bioequivalence/bioavailability studies compare the pharmacokinetics of two formulations of a drug.

  • Bioequivalence studies compare the rate and extent of absorption of a test drug to a reference drug

  • Bioavailability studies measure the amount of a drug that enters the bloodstream and the rate at which it does so

  • These studies are important for ensuring that generic drugs are equivalent to their brand-name counterparts

  • They can also be used to compare different formulations of the ...read more

4d ago

Q. What is your experience in clinical trials?

Ans.

I have 3 years of experience working as a clinical research coordinator in various clinical trials.

  • Managed patient recruitment and enrollment processes

  • Coordinated study visits and collected data

  • Ensured compliance with study protocols and regulatory requirements

Asked in ICON

5d ago

Q. What are the steps involved in clinical research?

Ans.

Clinical research involves several steps from planning to publication of results.

  • Planning and designing the study

  • Obtaining necessary approvals and funding

  • Recruiting and enrolling participants

  • Collecting and analyzing data

  • Interpreting and reporting results

  • Publication and dissemination of findings

3d ago

Q. What does PI mean in clinical trials?

Ans.

PI stands for Principal Investigator in clinical trials.

  • PI is the lead researcher responsible for the overall conduct of the clinical trial.

  • They oversee the study, ensure protocol compliance, and are accountable for the safety and well-being of participants.

  • PIs are typically experienced physicians or scientists with expertise in the specific area of research.

  • Examples of PI roles include obtaining funding, designing the study protocol, analyzing data, and reporting results.

Asked in IKS Health

3d ago

Q. Why did you choose IKS Health?

Ans.

I chose IKS Health for its commitment to innovation and excellence in clinical research, aligning with my career goals and values.

  • IKS Health's reputation for pioneering research methodologies attracts me, as I value being at the forefront of clinical advancements.

  • The company's focus on patient-centered care resonates with my belief in prioritizing participant welfare in clinical trials.

  • I admire IKS Health's collaborative environment, which fosters teamwork and knowledge shari...read more

Asked in IKS Health

3d ago

Q. Why do you want to join clinical data management?

Ans.

I am passionate about contributing to the advancement of medical research and improving patient outcomes.

  • Passion for contributing to medical research

  • Desire to improve patient outcomes

  • Interest in data management and analysis

Q. What we know about Clinical trails...

Ans.

Clinical trials are research studies that test new treatments or interventions on human subjects.

  • Clinical trials are conducted to determine the safety and efficacy of new drugs, devices, or treatments.

  • They are typically divided into four phases, with each phase testing different aspects of the treatment.

  • Phase 1 trials test the safety of the treatment on a small group of healthy volunteers.

  • Phase 2 trials test the efficacy of the treatment on a larger group of patients with the...read more

Asked in Lotus Labs

2d ago

Q. What is MS Excel and MS powerpoint

Ans.

MS Excel is a spreadsheet program used for data organization and analysis. MS PowerPoint is a presentation software for creating slideshows.

  • MS Excel is used for creating spreadsheets, organizing data, performing calculations, and creating charts.

  • MS PowerPoint is used for creating presentations with slides, images, text, and multimedia elements.

  • Both MS Excel and MS PowerPoint are part of the Microsoft Office suite of applications.

  • MS Excel can be used to track clinical trial da...read more

6d ago

Q. What is SOP?

Ans.

SOP stands for Standard Operating Procedure.

  • SOP is a set of step-by-step instructions that outline how to perform a specific task or procedure.

  • It ensures consistency, quality, and compliance in research activities.

  • SOPs are used in various fields, including clinical research, to ensure standardized practices.

  • Examples of SOPs in clinical research include guidelines for participant recruitment, data collection, and adverse event reporting.

2d ago

Q. What is the difference between a Clinical Research Coordinator (CRC) and a Clinical Research Associate (CRA)?

Ans.

CRC is responsible for managing day-to-day operations of clinical trials, while CRA monitors and ensures compliance with protocols and regulations.

  • CRC manages day-to-day operations of clinical trials

  • CRA monitors and ensures compliance with protocols and regulations

  • CRC interacts more with study participants and collects data

  • CRA focuses on site visits and ensuring data accuracy

Asked in IKS Health

1d ago

Q. What is clinical research Role of Crc Cra investigator SAE

Ans.

Clinical research involves conducting studies to evaluate the safety and effectiveness of medical treatments and interventions.

  • Clinical research is the process of investigating the safety and efficacy of medical treatments, devices, or interventions in human subjects.

  • Clinical Research Coordinators (CRC) play a key role in managing and coordinating clinical trials, ensuring compliance with protocols and regulations.

  • Clinical Research Associates (CRA) monitor and oversee the con...read more

3d ago

Q. What are clinical trials, phase 1-4,sae,AE

Ans.

Clinical trials are research studies that test new treatments or interventions on humans. They are conducted in phases 1-4 and monitor for SAEs and AEs.

  • Clinical trials are research studies that test new treatments or interventions on humans

  • They are conducted in phases 1-4, with each phase serving a different purpose

  • Phase 1 trials are the first time a new treatment is tested on humans and focus on safety

  • Phase 2 trials test the effectiveness of the treatment and determine the o...read more

4d ago

Q. What is clinical research? Explain different logs. Explain essential documents.

Ans.

Clinical research involves studying the safety and effectiveness of new medical treatments or interventions.

  • Clinical research is the process of investigating the safety and effectiveness of new medical treatments, interventions, or devices.

  • Different logs in clinical research include subject screening logs, drug accountability logs, and adverse event logs.

  • Essential documents in clinical research include the protocol, informed consent forms, case report forms, and investigator'...read more

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