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Assistant CRA (ACRA) | Brisbane, Perth

  • Source: LinkedIn
  • Thermo Fisher Scientific
  • Remote
  • Brisbane
  • Full-Time
  • Mid level

Job Description

Work Schedule Standard (Mon-Fri)

Environmental Conditions Office

Join Us as an Assistant Clinical Research Associate – Make an Impact at the Forefront of Innovation!

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead. As an Assistant Clinical Research Associate (ACRA) , you’ll provide support with site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. You may be assigned limited site contact activities during study start-up, site management, recruitment, and close-out phases.

What You’ll Do:

  • Complete assigned study and site management activities in accordance with the task matrix, SOPs, and study requirements.
  • Complete required study-specific training and become proficient in study systems.
  • Support site start-up activities, including pre-study assessments, site documentation, ICF customization, and vendor qualification.
  • Coordinate site readiness by managing system access, site staff training, study supplies, and meeting logistics.
  • Review and maintain essential documents, site information, and study trackers to ensure data accuracy and regulatory compliance.
  • Support remote monitoring activities, including EMR/EHR reviews, centralized monitoring, document reconciliation, and follow-up on missing study data.
  • Assist with site payments, invoice follow-up, and reconciliation of CRFs, queries, deviations, SAEs, and other study records.
  • Collaborate with CRAs, Clinical Leads, sites, and cross-functional teams to support study execution throughout the study lifecycle.
  • Complete administrative responsibilities, including timesheets, expense reports, and other assigned tasks.
  • Perform additional site management or client-specific responsibilities as assigned.

Location Information This is a home-based position and preferably based in Brisbane or Perth. Education and Experience Requirements:

  • Bachelor’s degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
  • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

  • Basic medical/therapeutic area knowledge and understanding of medical terminology
  • Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
  • Effective oral and written communication skills
  • Excellent interpersonal and customer service skills
  • Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
  • Proven flexibility and adaptability
  • Ability to work in a team or independently, as required
  • Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
  • Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
  • Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
  • Excellent English language and grammar skills
  • May require travel. (Recruiter will provide more details.)
  • Australian citizenship or permanent residency required

*…

Skills

  • acra
  • microsoft-forefront
  • provide-support
  • google-cloud-platform

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