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[Remote] Clinical Research Associate

Remote · Malaysia Full-time

Note: The job is a remote job and is open to candidates in USA. AstraZeneca is a global biopharmaceutical company dedicated to the discovery and development of innovative medicines. They are seeking a Field Based Clinical Research Associate to manage the delivery of clinical studies at allocated centers, ensuring compliance with international guidelines and local regulations.

Responsibilities

  • Local responsibility for the delivery of the studies at allocated centers
  • Active participants in the local study team(s)
  • Work in close collaboration with other Monitors and the Local Study Delivery Team
  • Ensure that quality and quantity commitments are achieved in a timely and efficient manner
  • Responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations
  • Deliver according to the commitment in the individual trials
  • Take on additional responsibilities that include additional tasks associated with Lead CRA, Senior CRA and/or Site Liaison

Skills

  • Bachelor's degree, preferably in Life Science discipline
  • 1.5+ years of CRA experience in Cardiovascular/Metabolic, Respiratory and/or Immunology therapeutic experience
  • Fluent knowledge of spoken and written English
  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP
  • Good knowledge of relevant local regulations
  • Good medical knowledge in relevant AZ Therapeutic Areas
  • Basic understanding of the drug development process
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management
  • Ability to travel as required, 50-70%
  • Ability to deliver quality according to the requested standards
  • Ability to work in an environment of remote collaborators
  • Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business
  • Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time
  • Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
  • Good analytical and problem solving skills
  • Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
  • Good cultural awareness
  • Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment
  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

Benefits

  • Overtime pay when working qualifying overtime hours
  • Short-term incentive bonus opportunity
  • Eligibility to participate in our equity-based long-term incentive program (salaried roles)
  • Retirement contribution (hourly roles)
  • Commission payment eligibility (sales roles)
  • Qualified retirement program [401(k) plan]
  • Paid vacation and holidays
  • Paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans
  • Individualized flexibility
  • Ways of working allow employees to balance personal and work commitments
  • Engaging face-to-face in our offices 3 days a week
  • Accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process

Company Overview

  • AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor. It was founded in 1913, and is headquartered in Cambridge, Cambridgeshire, GBR, with a workforce of 10001+ employees. Its website is https://www.astrazeneca.com.
  • Company H1B Sponsorship

  • AstraZeneca has a track record of offering H1B sponsorships, with 2 in 2021, 11 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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