CRA 2, Single-Sponsor Dedicated

IQVIA LLC; Amsterdam; Hybrid; EUR 45,000 - 64,000; Full time

Benefits offered by this job

Company car or mobility allowance

Wellness reimbursement

Pension plan

Insurance coverages

Job summary

IQVIA LLC in the Netherlands is seeking a Site Monitoring CRA to ensure sites conduct studies per protocol, GCP, ICH, and sponsor requirements, with on-site oversight.

Responsibilities include monitoring visits, site training, data quality, regulatory submissions tracking, TMF/ISF maintenance, and collaboration with the study team to meet recruitment and study timelines.

Qualifications

• Bachelor's Degree in scientific discipline or health care is required.
• Requires at least 1 year of on-site monitoring experience as a CRA.
• Dutch proficiency at C1 level or above is a must.
• Written and verbal communication skills including good command of English language.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (GCP and ICH).
• Good therapeutic and protocol knowledge as provided in company training.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., GCP/ICH.
• 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, CRF completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals site documents are available for filing in the TMF and verify ISF maintenance.
• Create and maintain documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and follow-up letters.
• 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.

Skills

On-site monitoring experience

Dutch language proficiency (C1+)

English communication skills

GCP/ICH knowledge

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. Please note: for this role you must be based in the Netherlands.

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) 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.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care is required.
• Requires at least 1 year of on-site monitoring experience as a CRA.
• Dutch proficiency at C1 level or above is a must.
• Written and verbal communication skills including good command of English language.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.

What we offer

IQVIA provides a car (with private use) or a mobility allowance, fuel, insurance, maintenance, plus essential work equipment (laptop, and iPhone).

Strong focus on professional growth, with access to learning and development resources, training programs, and opportunities to continuously build clinical and leadership expertise.

Home office setup support and an annual wellness reimbursement for sport and wellbeing activities.

Leave policy, including annual vacation days and additional year-end leave options.

Comprehensive benefits package including pension plan, multiple insurance coverages, and optional partial reimbursement of supplementary health insurance, plus social and wellbeing activities.

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 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. 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.