Thermo Fisher Scientific logo
Thermo Fisher Scientific

The World Leader In Serving Science

Assistant CRA – ACRA

AssistantGeneralFull TimeRemoteSeniorTeam 10,001+Since 1956H1B SponsorCompany SiteLinkedIn

Location

Australia

Posted

9 days ago

Salary

0

Seniority

Senior

Bachelor DegreeExperience acceptedEnglishGoogle Cloud Platform

Job Description

Assistant CRA – ACRA

Thermo Fisher Scientific

• Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned. • Completes and documents study-specific training. • Orients and trains on any study-specific systems. • Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project. • Supports to customize Site ICF with site contact details, as needed. • Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments. • Verifies document collection and RCR submission status; updates site EDL and verifies site information. • Reviews patient facing materials and review translations, as directed. • Supports site staff with the vendor related qualification process, where applicable. • Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study. • Provides support to follow-up on site staff training, as applicable. • Coordinates and supports logistics for IM attendance, as directed. • Supports maintenance of vendor trackers, as directed. • Coordinates study/site supply management during pre-activation and subsequent course of the study. • Supports Essential Document collection, review and updating in systems, as applicable. • Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed. • Supports ongoing remote review of centralized monitoring tools, as directed. • Supports Site payments processes by coordinating with various functional departments within organization and site. • Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period. • Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable. • Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed. • May perform other assigned site management tasks, as directed by CRA and as per Task Matrix. • May perform a specific role profile for FSP opportunities according to Client requests. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Job 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).
  • 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.

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.

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