Assistant Clinical Research Associate

Role overview

Thermo Fisher Scientific is hiring an Assistant Clinical Research Associate to support clinical study operations in a remote capacity, working in coordination with the CRA and the study Clinical Lead. The role focuses on helping with site readiness, monitoring-related logistics, and site management tasks while following SOPs and regulatory requirements. Depending on the study, you may also handle limited site-contact work during study start-up, recruitment, ongoing management, and close-out.

The organization notes that it has backed the top 50 pharmaceutical companies and more than 750 biotech organizations, contributing to 2,700 clinical trials across 100+ countries over the past five years.

Work schedule and environment

The position follows a standard Monday to Friday schedule. Work is primarily done in an office or home-office setting, and there may be occasional travel to clinics or hospitals. The role also involves exposure to normal office electrical equipment.

Key responsibilities

• Carry out study and site-management activities according to the assigned task matrix and project direction.
• Complete study-specific training and document it properly.
• Learn and support the use of study-specific systems.
• Assist with pre-study assessments and approved waivers when required by the project.
• Help tailor the site informed consent form with site contact details as needed.
• Conduct remote checks of EMR/EHR checklists and support related data collection where applicable.
• Track document collection and RCR submission progress, maintain site EDL records, and confirm site details.
• Review patient-facing documents and translation versions as instructed.
• Support site staff through vendor qualification steps when applicable.
• Help request, grant, and revoke system access for site staff during pre-activation and later study stages.
• Follow up on site staff training requirements.
• Coordinate and support logistics for investigator meeting attendance.
• Maintain vendor trackers and study supply coordination during pre-activation and throughout the study.
• Support collection, review, and updates of essential documents within study systems.
• Follow up on missing vendor data such as ECGs, lab samples, and e-diaries.
• Assist with ongoing remote review of centralized monitoring tools.
• Support site payment activities by coordinating with internal teams and sites, updating systems, reconciling records, and tracking invoices.
• Perform trial reconciliation tasks including CRF/query status, deviations, SAEs, and safety reports as applicable.
• Check document collection status in company systems and drive follow-up for missing, incomplete, expired, or open document issues.
• Take on other site-management duties assigned by the CRA in line with the task matrix.
• Support specific FSP role profiles when client requirements call for it.
• Keep administrative work such as expense reports and timesheets current and accurate.

Education and experience

A bachelor’s degree in life sciences or a related field is preferred, or a registered nursing certification, or an equivalent formal academic/vocational qualification. Candidates with a combination of relevant education, training, and direct experience may also be considered. Prior experience should be sufficient to cover the job requirements and is typically in the 0 to 2 year range.

Knowledge and skills

The role calls for basic understanding of medical and therapeutic areas, familiarity with medical terminology, and the ability to build working knowledge of ICH GCP, applicable regulations, and internal procedures. Strong communication, interpersonal, customer-service, organization, time management, attention to detail, adaptability, teamwork, independent working, critical thinking, root-cause analysis, and problem-solving abilities are important. Good computer skills are also needed, including MS Office and the ability to learn related software and use modern tools when relevant. You should be able to pull key information from study documents, electronic systems, CTMS platforms, and dashboards, and communicate clearly in English with strong grammar.

Additional working notes

The Assistant CRA position itself does not normally require regular travel. However, progression into direct CRA roles within the career track may involve frequent travel, typically around 60% to 80%.