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 can be either home based anywhere in the Netherlands or at our office in Amsterdam. The office is open planned, and you will be working in an innovative and collaborative environment.
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 Senior 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.QualificationsMore about you On your first day we’ll expect you to have:- Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
-The ability to function as a mentor and role model for other CRAs.- 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.Knowledge and Experience:- Advanced level and strong comprehensive site management or equivalent Sr CRA experience or advanced level onsite monitoring experience in clinical research with understanding of clinical trials methodology and terminology- Very strong and advanced previous onsite clinical monitoring experience is essential in the capacity of a CRA II or Sr CRA or equivalent performing all types of visits .
– Must hold a full driving license – Must be willing to travel approx 1.5 – 2 days per week.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 “super user” 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.
In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary, company car, plus the CRA bonus scheme as well as a benefits package including holiday per year, pension scheme as well as other leading edge benefits that you would expect with a company of this type.If you are ready to join Parexel’s Journey, please apply
You are only one step away from being able to work remotely from anywhere. Fill out your email address here and then you will be directed to the application page for this remote job position. Good luck!