CRA , Single-Sponsor Dedicated

Amsterdam, Netherlands | Full time | Home-based | R1552279

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.

• 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

• Bachelor's Degree in a scientific discipline or health care is required
• At least 3 months of onsite monitoring experience is a must
• 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

• 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