Clinical Research Associate (CRA II/Senior) - Bilingual French/English

Parexel

• $80K — $95K *
US-Anywhere
+ 8 other locationsRemote
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 18+ months of direct onsite monitoring experience as a Clinical Research Associate (CRA)
  • Bachelor's or equivalent degree in biological science, pharmacy, or a health-related discipline
  • Strong interpersonal, written, and verbal communication skills
  • Ability to work independently with a sense of urgency
  • Client-focused approach with a flexible attitude
  • Capability to manage multiple tasks and unpredictable scenarios
  • Strong computer skills, including knowledge of CTMS, EDMS, and MS-Office
  • Fluency in both English and French

Responsibilities

  • Conduct qualification, site initiation, monitoring, and termination visits at clinical sites
  • Build and maintain relationships with site staff to ensure study integrity
  • Review trial performance to safeguard patient rights and well-being
  • Develop patient recruitment strategies to meet enrollment timelines
  • Evaluate the quality and integrity of reported data and drug accountability
  • Monitor regulatory documentation completeness and perform site document verification

Benefits

  • World-class technology and training tailored to individual experience
  • Less travel and lower protocol load compared to industry peers
  • Bonus incentive program for hard work
  • Opportunity to work across multiple therapeutic areas
  • Career advancement opportunities in clinical research
Full Job Description

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 are set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You will 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 may 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 completeness and quality of Regulatory Documentation and perform site document verification.

A little about us

Parexel is proud to be a leading Clinical Research Organization with team members across the globe. As a member of our team, you will get to know your colleagues on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or colleague are a phone call away. Our clinical research teams meet regularly to have discussions in a 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.

More about you

On your first day we’ll expect you to have:

  • 18+ months of direct onsite monitoring experience as a Clinical Research Associate (CRA)
  • Bachelors or equivalent degree in biological science, pharmacy or other health related discipline.
  • Strong interpersonal, written, and verbal communication skills within a matrixed team.
  • Ability to work in a self-driven capacity with a sense of urgency and limited need for oversight.
  • A client focused approach to work with a flexible attitude with respect to assignments and 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.
  • Fluency (written & spoken) in both English and French

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