Associate Clinical Research Associate, Single Sponsor dedicated in Poland

IQVIA is hiring Associate Clinical Research Associates!

Join IQVIA today and make an impact on patients outcome!

Job Overview
Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol standard operating procedures good clinical practice and applicable regulatory requirements.

Responsibilities

• Complete appropriate therapeutic protocol and clinical research training to perform job duties.
• Gain experience in study procedures by working with experienced clinical staff.
• Under close supervision perform site monitoring visits (selection initiation monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
• Under close supervision administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Under close supervision 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.
• Under close supervision ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigators Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements.
• Under close supervision may support start-up phase.
• Under close supervision 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 learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress.

Qualifications

• A Bachelors degree in a health care or other scientific discipline or educational equivalent
• Prior clinical experience preferred. Some organizations may require 2 years of clinical experience.
• Advanced knowledge of applicable clinical research regulatory requirements i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Computer skills including proficiency in use of Microsoft Word Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of Polish and English language

Connect to great opportunity

IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees builds a stronger team and allows individual employees the opportunity to maximize their personal potential.

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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

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.