Clinical Research Associate, Sponsor Dedicated

NCBioImpact; Durham (NC); On-site; USD 64,000 - 189,000; Full time

Job summary

IQVIA is seeking a Clinical Research Coordinator to ensure sites conduct studies and report data per protocol, regulations, and sponsor requirements. The role involves nationwide travel (65–70%), site visits, and collaboration with the study team to manage timelines and deliverables.

Requirements include 2.5 years of site-level coordination, a life sciences bachelor’s degree, and preferred knowledge of electronic data capture.

Qualifications

• 2.5 years of clinical research coordination at site level.
• Nursing or University Degree (US Bachelor level or equivalent) in life sciences.
• Knowledge of electronic data capture preferred.
• Equivalent combination of education, training and experience.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per GCP/ICH.
• Drive and track subject recruitment plan to meet project needs.
• Administer protocol training and maintain regular site communications.
• Evaluate site practice quality and regulatory adherence; escalate issues.
• Track regulatory submissions, recruitment, CRF completion and data queries.
• Ensure TMF/ISF documents are maintained per local requirements.
• Create visit reports, follow-up letters and site documentation.
• Collaborate with study team for project execution support.
• Support development of recruitment plans per site; assist site finance when needed.

Skills

Clinical research coordination

Site monitoring

Regulatory compliance

Education

Bachelor's degree life sciences

Tools

EDC knowledge

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. Position requires 65-70% nationwide travel.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• 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) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH 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.
• 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.

MINIMUM RECRUITMENT STANDARDS:

• 2.5 years of clinical research coordination experience at site level
• Nursing or University Degree (US Bachelor Level or equivalent) in one of the life sciences
• Knowledge of electronic data capture preferred
• Equivalent combination of education, training and experience

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. Learn more at https://jobs.iqvia.com

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 $64,000.00 - $189,000.00. 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.