Parexel

Clinical Research Associate I – II

Parexel

full-time

Posted on:

Location Type: Remote

Location: Australia

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Tech Stack

Google Cloud Platform

About the role

  • Act as Parexel’s direct contact with assigned sites
  • Assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
  • Perform problem-solving to address and resolve site issues
  • Build relationships with investigators and site staff
  • Facilitate and support site with access to relevant study systems
  • Ensure sites are compliant with project specific training requirements
  • Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary
  • Address and resolve issues at sites, including additional training and communication
  • Collect, review, and approve updated/amended site documentation
  • Perform on-site visits including Qualification and Initiation visits
  • Conduct remote visits/contacts as requested/needed
  • Monitor and maintain compliance with ICH-GCP and applicable international and local regulations
  • Ensure timely and accurate completion of project goals and update applicable trial management systems
  • Provide strategy for efficient project planning and goal completion
  • Ensure that assigned sites are audit and inspection ready

Requirements

  • CRA experience from AUS or NZ is required (at least 1 year of independent monitoring)
  • Sound problem solving skills.
  • Able to take initiative and work independently, and to proactively seek guidance when necessary.
  • Advance presentation skills.
  • Client focused approach to work.
  • Ability to interact professionally within a client organization.
  • Flexible attitude with respect to work assignments and new learning.
  • Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decisions autonomously due to the unpredictable nature of the issues that arise.
  • Willingness to work in a matrix environment and to value the importance of teamwork.
  • 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.
  • Strong interpersonal, verbal, and written communication skills.
  • Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
  • Effective time management in order to meet study needs, team objectives, and department goals.
  • Developing ability to work across cultures.
  • Shows commitment to and performs consistently high-quality work.
  • Able to accommodate extensive travel time requirements, according to task allocation/phase of the study assigned.
  • Holds a driver’s license where required.
Benefits
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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CRA experienceindependent monitoringproblem solvinganalytical skillstime managementproject planningstudy protocol adherencesite documentation reviewon-site visitsremote visits
Soft Skills
initiativeclient focusedprofessional interactionflexibilityprioritizationteamworkcommunicationsense of urgencycommitment to qualitycultural awareness