Clinical Research Associate II

Parexel; Poland; Remote; PLN 120,000 - 180,000; Full time

Job summary

Parexel is seeking an experienced Clinical Research Associate to join our Multi-Sponsor Clinical Trials Team in Poland. You will be the site’s sole point of contact, managing visits from site initiation to close-out while ensuring patient safety and data integrity.

The role offers exposure to world-class technology and training, with less travel and a bonus incentive program. You will advance your career in clinical research across multiple therapeutic areas with Parexel.

Qualifications

• Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
• Ability to perform all clinical monitoring activities independently.
• Experience with Oncology trials would be an advantage.
• Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.
• Strong interpersonal, written, and verbal communication skills within a matrixed team.
• Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
• The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while understanding study protocols.
• An honest and ethical work approach to promote the development of life changing treatments for patients.
• Strong computer skills, including CTMS, EDMS and MS-Office products such as Excel and Word.

Responsibilities

• 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 problem-solving skills to promote rapport with the site and staff.
• Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being 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 SOPs, protocol/amendments, GCP, and applicable regulatory requirements.
• 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.

Skills

Clinical research

Site management

CTMS

EDMS

MS Office

Oncology trials

Communication skills

Independent working

Client-focused

Education

Bachelor's degree in biological science or related health field

Tools

CTMS

EDMS

MS-Office

Job description

Parexel is in the business of improving the world’s 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 currently seeking an experienced Clinical Research Associate to join our Multi-Sponsor Clinical Trials Team in Poland.

Your time here

At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You’ll also manage site quality and delivery from site identification through to close-out.

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 you’ll 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 problem-solving skills to promote rapport with the site and staff.

• Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being 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 we’ll expect you to have:

• Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.

• Ability to perform all clinical monitoring activities independently.

• Experience with Oncology trials would be an advantage.

• Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.

• Strong interpersonal, written, and verbal communication skills within a matrixed team.

• Experience working in a self-driven capacity, with a sense of urgency and limited oversight.

• A client-focused 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 MS-Office products such as Excel and Word.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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