Who is a CRC?
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using
good clinical practice (GCP) under the instructions from a Principal Investigator (PI).
A health care professional who, under the supervision of the investigator, submits all research
documents to IRB, schedules and implements the study visit requirement, co-ordinates all the tests
and procedures for the study.
He/she commits with the ‘real life’ responsibilities and these responsibilities have legal
consequences.
After the Principal investigator, the CRC is the most important clinical research person at the site!
The perfect Clinical Research Coordinator can be:
1. Nurse
2 Doctor
3. Physician
4. Adequately trained Medically trained personnel
CRC is multifaceted and the basic skills and personality of CRC that is looked out at are the following-
• Administrative
• Business
• Medical
• People oriented
• Good organizational skills
• Ability to multi-task
• Attention to details
Now, let’s understand the job responsibilities of the CRC and few of the responsibilities are listed
below-
1. Recruitments, Compare the IRB requirements to the protocol
requirements. If they differ, remember you’re required to meet both
2. Reviewing new protocols, IB and other study materials submitted by the
sponsor.
3. Training/mentoring additional staff
4. Preparing the site for the clinical trial
5. Developing the informed consent form/document
6. Executing the informed consent
7. Investigational product accountability
8. Scheduling visits for seeing subjects, time to review study progress with
the principal investigator, visits with the Monitor.
9. Maintaining clinical trial documents/records. 10. Interacting with institutional review board /clinical research organization
/Contract Labs/Sponsor.
11. Developing and executing study budget.
12. Hosting Monitors/Auditors/Inspectors.
13. Finding new studies for the research practice.
14. Protocol requirements, and a ‘preliminary assessment’ of medical charts
if the Principal investigator has patients who meet the criteria and can
become subjects in the clinical trial.
There are two major goals of CRC at the site:
• Subject Protection
• Data Integrity
Let’s understand how important these goals are for the CRC-
Subject Protection
• Note all elements of the Informed Consent were incorporated.
• Note all signatures are performed appropriately.
• For example, some site personnel write the subject’s name on the ICF
and let the subject sign in the form.
• Study procedures were conducted before the consent was signed.
• Some allow subjects to sign at home instead of in their presence.
• Ensure the language of the consent be understandable by the
potential subjects.
• Allow subjects sufficient time to ask questions.
Data integrity
• Create case histories that are complete and convey accurate
information.
• Explain corrections made in the CRF and source documents to dates
and measurements.
• Write the same information in each record to make sure the content
matches.
• Explain/justify protocol deviations.
• Minimize the number of protocol deviations at your site.
• Checks and balances in your site practices to make sure the
investigational plan (i.e. protocol, CRF guidelines, etc.) is followed
and all inconsistencies resolved.
• Let your documentation tell “the site’s story”.
CRC also has a leading hand in developing the SOP’s (Standard Operating Procedure) and
making sure everybody follows them.
SOPs are a testament to the way you do business and a sure way of obtaining data integrity.
Not required by regulation but ‘expected’ by sponsors. Ensures consistency in job performance. Clarifies to staff, the Principal investigator delegation of responsibility (who does what).Describes the task and minimize micro-managing/training.
Then how does the CRC end up with ‘responsibilities and commitments’ in clinical research?
ICH E6 4.1.5 – The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.
Summary:
- The CRC’s responsibilities are delegated by the investigator.
- The CRC should receive clearly delegated duties in writing from the PI.
- The Principal investigator is required to ensure the CRC is qualified by experience and training to perform delegated duties. (21 CFR 312.5)
- Principal investigator can delegate clinical trial responsibilities, but they can NOT delegate ‘trial accountability’.
- They can be debarred if they commit scientific or research misconduct.
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