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Thermo Fisher Scientific

Assistant CRA (ACRA)

RemoteAustralia only· Prefers Australia
Published
Experience
Junior
Employment
Full-time
Company size
Enterprise
Salary not disclosed
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Open to AU only · Prefers Australia. Set where you work from to check your eligibility.

The listing prefers candidates in Australia.

No BS summary

Assistant Clinical Research Associate (ACRA) needed to support clinical trial site preparedness and monitoring. Requires a Bachelor's degree in life sciences or nursing, with 0-2 years of experience. Must have basic medical knowledge, understanding of GCP, and strong organizational skills. Australian citizenship or permanent residency required.

Required skills

MS Office

Required languages

English

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.
  • Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead.
  • 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.
  • May be assigned limited site contact activities during study start-up, site management, recruitment, and close-out phases.

What they require

  • 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.
  • 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

Benefits

  • Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
  • Balance your work and personal life with flexible arrangements.
  • Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
  • Make an impact with paid volunteer time to support non-profit organizations that matter to you.
  • Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
  • Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality

multinational company providing scientific instrumentation

Life SciencesEnterprisethermofisher.com/

What people say about this company

3.4/ 5

Salary not disclosed