Cohesive Technologies
Position Overview
We are seeking experienced Good Clinical Practice (GCP) IT Auditors to join our client IQVIA/Harman for a 6+ month contract. This role is based onsite or hybrid in Raleigh, NC or King of Prussia, PA, with 40% travel required.
As a GCP IT Auditor, you will play a critical role in evaluating clinical research trials and processes to ensure compliance with ICH E6 guidelines, FDA regulations, and GCP standards. You will be responsible for conducting audits at trial sites, investigator facilities, and clinical research organizations (CROs), ensuring both data integrity and patient safety.
This opportunity is ideal for professionals with 5+ years of experience in clinical research auditing, monitoring, or trial management, looking to advance their expertise in compliance and quality assurance.
Key Responsibilities of a GCP IT Auditor
-
Conduct detailed audits of clinical trial sites, investigator locations, and CROs.
-
Review study protocols, consent forms, and case report forms (CRFs) for compliance with GCP and regulatory standards.
-
Evaluate trial execution processes, including subject recruitment, eligibility, data collection, and adverse event reporting.
-
Verify adequacy of site facilities, equipment, and personnel training.
-
Assess the completeness of trial documentation and regulatory submissions.
-
Identify compliance gaps, deviations, and risks during audits.
-
Recommend and track corrective and preventive actions (CAPA) with stakeholders.
-
Prepare professional audit reports with observations and recommendations.
-
Keep up to date with ICH, FDA, and local GCP regulations.
-
Work closely with sponsors, investigators, and coordinators to promote compliance awareness.
-
Maintain high levels of confidentiality, ethics, and professional conduct.
Qualifications and Experience Required
-
Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. A Master’s or Ph.D. is an advantage.
-
At least 5 years of clinical research experience in trial management, auditing, or monitoring.
-
Deep knowledge of GCP regulations (ICH E6), FDA regulations, and industry best practices.
-
Proven track record of conducting clinical trial audits in sponsor, CRO, or consultant settings.
-
Strong report writing, communication, and risk assessment skills.
-
Willingness to travel 40% of the time for site audits.
Why This Role is Important
Clinical trials are the backbone of medical innovation. The role of a GCP IT Auditor is to ensure that these trials are conducted with integrity, accuracy, and ethical standards. Your expertise will directly impact the quality of data, patient safety, and compliance with global regulations.
Work Model and Locations
-
Location: Raleigh, NC or King of Prussia, PA
-
Work Model: Onsite or Hybrid
-
Travel: 40% required
Ready to Apply?
If you are ready to advance your career as a GCP IT Auditor, take the next step today.
👉 Check out other positions on RishiWrites.com
👉 Let’s discuss your next career move
FAQs (15)
-
What is the main role of a GCP IT Auditor?
A GCP IT Auditor reviews and evaluates clinical trials to ensure compliance with GCP guidelines and regulations. -
Which companies are hiring for this role?
The client for this role is IQVIA/Harman. -
What is the contract duration?
The initial duration is 6 months with the possibility of extension. -
Where is the job located?
Raleigh, NC or King of Prussia, PA with a hybrid or onsite model. -
How much travel is involved?
About 40% travel to audit sites. -
What qualifications are needed?
A bachelor’s degree in life sciences, nursing, or related fields. Advanced degrees are preferred. -
How much experience is required?
At least 5 years in clinical research, trial monitoring, or auditing. -
What skills are essential for this role?
Strong knowledge of GCP regulations, FDA compliance, auditing, and report writing. -
Is prior auditing experience mandatory?
Yes, candidates must have hands-on auditing experience. -
What type of audits will I conduct?
Site audits, CRO audits, investigator site audits, and clinical trial documentation reviews. -
Will training be provided?
Experienced auditors are expected to work independently, but client-specific guidance will be given. -
What is GCP compliance?
Good Clinical Practice ensures the rights, safety, and well-being of trial participants and data integrity. -
Is this a remote job?
No, it is hybrid or onsite with significant travel. -
What industries benefit from GCP auditing?
Pharmaceutical, biotech, and clinical research industries. -
How do I apply for this position?
You can apply directly through RishiWrites.com or connect on LinkedIn.
