Clinical Research Associate II

Parexel; Madrid; On-site; EUR 38,000 - 56,000; Full time

Job summary

Parexel is seeking a Clinical Research Associate (CRA) based in Madrid or Barcelona. As the site contact, you will monitor sites, ensure patient safety, manage study quality, and support site initiation and close-out, with reduced protocol load and travel compared with peers.

You will build site relationships, drive patient recruitment strategies, ensure compliance with SOPs and GCP, and advance your career through Parexel's training and programs.

Qualifications

• Site Management or equivalent experience in clinical research.
• Fluent command of Spanish and English (written and oral). Knowledge of Portuguese would be an advantage.

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/report notes.
• Build relationships and oversee study integrity, promoting rapport with site staff.
• Protect patients by ensuring rights and well-being are safeguarded and in line with the protocol.
• Drive recruitment strategies with the site to meet enrollment timelines while complying with SOPs, protocols and GCP.
• Ensure quality by evaluating data integrity, site efficacy and drug accountability.
• Execute site documentation verification and regulatory documentation review.

Skills

Site management experience

Fluent Spanish & English

Communication skills

Self-driven / urgency

CTMS/EDMS proficiency

Education

Bachelor’s degree in biological science or related health discipline

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.

This role is based in the regions of Madrid or Barcelona.

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

• Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
• Ability to perform all clinical monitoring activities independently.
• 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.
• Fluent command of Spanish and English (written and oral). Knowledge of Portuguese would be an advantage.
• 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.