Experienced Clinical Research Associate, Site Management Poland

IQVIA; Warszawa; Sur place; PLN 133 000 - 280 000; Plein temps

Résumé du poste

IQVIA in Poland seeks experienced CRAs for its Site Management Team to conduct on-site monitoring across multiple sites in line with GCP/ICH guidelines. You will manage recruitment tracking, site communications, and regulatory submissions while ensuring TMF/ISF accuracy and quality control.

The role requires travel, strong communication skills, and fluency in Polish and English, with the ability to handle multiple protocols and sites effectively.

Qualifications

• Independent on-site monitoring experience.
• Experience across multiple protocols and sites.
• Willingness to travel and flexibility.

Responsabilités

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP/ICH.
• Collaborate with sites to drive subject recruitment plans aligned with project needs.
• Administer protocol training to sites and maintain regular site communication.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion, data queries, and resolutions.
• Maintain TMF and ISF documentation in line with GCP and local requirements.
• Prepare site visit reports and follow-up letters, and maintain study docs.
• Coordinate with study team for project execution support.

Connaissances

On-site monitoring experience

Travel flexibility

Strong communication skills

Fluent Polish and English

Formation

Life science degree

Description du poste

Opportunity in a dynamic multi‑sponsor environment - we are looking for experienced CRAs for our Site Management Team in Poland!

Responsibilities

• 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
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Requirements

• You should be life science degree educated
• You have experience of independent on-site monitoring experience
• You've handled multiple protocols and sites across a variety of drug indications
• Flexibility and ability to travel
• Strong communication, written and presentation skills
• Fluent language skills in Polish and English

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.

The potential base pay range for this role, when annualized, is 132.800,00 zł - 280.000,00 zł. 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.