Research Team Clinical Data Associate

@ Thermo Fisher Scientific

Overview

Phase I and IB trials represent the first practical tests of a compound’s clinical relevance and commercial viability. As a Research Team Clinical Data Associate at Thermo Fisher Scientific, you will receive comprehensive training to complete multiple administrative functions for ongoing clinical trials involving patients or healthy volunteers. You will work in a hands-on, team-oriented environment.

Summarized Purpose

Under the direction of the Research Team Leader, you are responsible for the successful completion and filing of case report forms and source documents for clinical research studies. You will collaborate with sponsor representatives during meetings/visits to review case report form data and ensure proper archival of study information.

Essential Functions

• Develop a filing system for each study ensuring accessible subject folders.
• Ensure folders are complete, accurate, and audited for data integrity.
• Identify and flag data discrepancies for resolution by appropriate staff.
• Document study issues to maintain clarity over time.
• Review protocols and CRFs and address gaps in information.
• Ensure accurate and timely completion of CRFs to meet sponsor requirements.
• Coordinate with the principal investigator and QA for data accuracy.
• Set up sponsor rooms prior to visits and resolve sponsor queries post-study.

Qualifications

A high/secondary school diploma or equivalent is required, with a preference for candidates holding a Bachelor's Degree. At least 2 years of relevant experience or an equivalent combination of education, training, and experience is expected.

Knowledge, Skills and Abilities

• Ability to manage multiple responsibilities and projects.
• Proficient in Microsoft Office and adaptable to new systems (e.g., Oracle database).
• Strong communication and interpersonal skills.
• Excellent attention to detail, planning, and organization.
• Strong auditing and documentation skills.
• Willingness to learn methods for administering investigational drugs or devices.

Working Environment

The role is based in an office setting with potential exposure to non-traditional work environments and standard laboratory hazards. The candidate must be able to work upright, lift objects up to 25 pounds, and perform under pressure while managing multiple tasks.

Key skills/competency

Clinical Trials, Data Management, CRF, Auditing, Documentation, Filing, Communication, Microsoft Office, Oracle, Organization