Clinical Research Associate II in Poland

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Parexel is in the business of improving the worlds health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory consulting and market access our therapeutic technical and functional ability is underpinned by a deep conviction in what we do. We believe in our values Patients First Quality Respect Empowerment & Accountability.

We are seeking an experienced CRA to join our successful Clinical Operations Team in Poland.

This role can be officebased in Warsaw or decentralized in Poland.

Your time here

At Parexel the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRAs are accountable for using their expertise to build and maintain the site relationship and ensure theyre set up for success. As the clinical sites sole point of contact this includes addressing and resolving site issues and questions. Youll also manage site quality and delivery from site identification through to closeout.

As a CRA Parexel will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work may be rewarded through a bonus incentive program the opportunity to work within multiple therapeutic areas and an opportunity to advance your career in clinical research. If impact flexibility and career development appeal to you Parexel could be your next home.

What youll do

• Leverage your expertise. Conduct qualification visits (QV) site initiation visits (SIV) monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
• Build relationships. Oversee integrity of the study and utilize problemsolving skills to promote rapport with the site and staff.
• Protect patients. Review the performance of the trial at designated sites ensure the rights and wellbeing of human subjects are safeguarded and are in accordance with protocol.
• Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines while also ensuring compliance with the approved standard operating procedures (SOPs) protocol/amendment(s) GCP and the applicable regulatory requirement(s).
• Ensure quality. Evaluate the quality and integrity of the reported data site efficacy and drug accountability.
• Execute. Monitor the completeness and quality of Regulatory Documentation and perform site document verification.

More about you

On your first day well expect you to have:

• Previous Site Management experience and strong understanding of clinical trials methodology and terminology.
• Ability to perform all clinical monitoring activities independently.
• Bachelors or equivalent degree in biological science pharmacy or other health related discipline.
• Strong interpersonal written and verbal communication skills within a matrixed team.
• Fluent command of the Polish and English languages (written and oral).
• Experience working in a selfdriven capacity with a sense of urgency and limited oversight.
• A clientfocused approach to work and flexible attitude with respect to assignments/new learning.
• The ability to manage multiple tasks evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).
• An honest and ethical work approach to promote the development of life changing treatments for patients.
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS) Electronic Document Management System (EDMS) and MSOffice products such as Excel and Word.

If you are ready to join Parexels Journey please apply!