Sr. CRA 1, IQVIA

IQVIA LLC; Durham (NC); On-site; USD 90,000 - 175,000; Full time

Job summary

IQVIA LLC is seeking an on-site Monitoring Specialist to ensure sites conduct studies according to protocol, GCP, and regulatory standards. The role involves monitoring visits, site training, and close collaboration with study teams across multiple sites.

You will track regulatory submissions, recruitment, CRF completion, and data queries while supporting start-up activities. A background in clinical research and at least 2 years on-site monitoring is required.

Qualifications

• Bachelor's degree in a scientific discipline or healthcare.
• Requires at least 2 years of on-site monitoring experience.
• Good knowledge of and ability to apply clinical research regulatory requirements.
• Familiarity with Good Clinical Practice (GCP) and ICH guidelines.
• Understanding of protocol and site management as provided in training.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and GCP.
• Collaborate with sites to recruit and manage subject recruitment plans.
• Administer protocol training to sites and maintain regular communication.
• Assess site practices for protocol compliance and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion, data queries; support start-up activities.
• Ensure site documents are filed in TMF and ISF is maintained per regulatory standards.
• Document site management activities and follow-up through reports and letters.

Skills

On-site monitoring

GCP/ICH knowledge

Regulatory compliance

Clinical trials

Education

Bachelor's degree in scientific discipline or health care

Job description

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Key Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Responsibilities / Essential Functions

• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $90,200.00 - $175,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.