Thermo Fisher Scientific Assistant CRA Opportunity

Thermo Fisher Scientific offers support to the top 50 pharmaceutical companies and over 750 biotechs across 2,700 clinical trials. The company invites an Assistant Clinical Research Associate to join the global team.

This remote or on-site role (Gauteng) involves liaison with the CRA and study Clinical Lead. You will provide logistical support to the monitoring process and assist with site management and remote monitoring activities.

• Site Responsibilities: Execute study and site management activities as defined in the task matrix.
• Pre-Study Support: Provide in-house support during pre-study assessments, waivers, and orient staff on study-specific systems.
• Documentation: Customize Site ICF with contact details, verify document collection, RCR submission status, and update site EDL.
• Remote Monitoring: Perform remote review of EMR/EHR checklists, centralized monitoring tools, and patient-facing materials.
• Operations: Support system access (activation/pre-activation), vendor tracking, supply chain management, and Essential Document collection.
• Safety & Compliance: perform reconciliation on CRF status, deviations, SAEs, and follow up on missing vendor data ordered materials.
• Administration: Perform expense reports, timesheets, and coordinate with internal departments for site payments.

• Complete study and site management activities as directed by the CRA.
• Complete study-specific training and orient on any study-specific systems.
• Provide in-house support during pre-study assessments and waivers.
• Assist customizing Site ICF with site contact details.
• Perform remote reviews of EMR/EHR checklists and support data collection.
• Verify document collection, RCR submission status, and maintain site EDL updates.
• Review patient facing materials and translations.
• Support vendor qualification processes and system access requests.
• Coordinate logistics for Investigator Meeting attendance and site supply management.
• Support Essential Document collection, review, and updates.
• Follow up on missing vendor data like ECGs, lab samples, and e-diaries.
• Perform reconciliation tasks on assigned trials (CRFs, deviations, SAEs).
• Maintain administrative tasks such as expense reports and timesheets.

• Education: Relevant Bachelor’s degree in life sciences or related field, or Registered Nursing certification.
• Experience: 0 to 2 years of experience providing the necessary knowledge and skills for the role. Equivalency via training and direct experience will be considered.
• Knowledge: Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Regulatory: Ability to attain and maintain working knowledge of ICH GCP, applicable regulations, and company procedural documents.