Site Visits Report Reviewer

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's 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 we're committed to making a difference.

We are looking for passionate experienced Sr CRAs to work remotely, completing tasks on behalf of the Clinical Operations Leader, reviewing monitoring reports.

Locations: Argentina, Brazil, Colombia, Chile, México or Peru.

Mandatory requirements:

• No less than 7 years of experience as Clinical Research Associate
• Advanced English level

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. generating and reviewing 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:

• At least 7 years of CRA experience
• Proficient in English
• 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.
• Experience working self-driven, 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.

A little about us

Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you’ll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology “superuser” or collaborator are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level CRA role, into line management, Quality, Project Leadership, or a variety of other positions, Parexel prides itself on career opportunities for our employees.