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Senior CRA

4 weeks ago

Kuala Lumpur, Kuala Lumpur, Malaysia Pharmaceutical Research Associates, Inc Full time
Overview

As a Sr. Clinical Research Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with one of our global pharmaceutical clients; a client with which ICON shares a culture of innovation, flexibility, and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in this exclusive program.

Responsibilities

What you will be doing:

  • Perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits and close-out visits.
  • Contribute to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e., operating manuals, monitoring guidelines, etc.).
  • Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks as instructed by the Project Manager.
  • Negotiate investigator budgets and assist with the execution of site contracts with support from the legal department.
  • Oversee all aspects of study site management to ensure high quality data resulting in consistently low query levels and good Quality Assurance reports.
Qualifications

You are:

  • Degree in Pharmacy or any related course.
  • 4+ years prior monitoring experience with global trials.
  • Experience with clinical trial set up and contract negotiation preferred, but not essential.
  • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP, and good knowledge of local regulations.
  • Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.

Why ICON?

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

Our success depends on the knowledge, capabilities, and quality of our people. That's why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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