Assistant CRA - Site Support Solutions at Thermo Fisher Scientific

Discover Impactful Work:

• The ACRA within Site Support Solutions will perform delegated activities at assigned investigator sites under the supervision of the Principal Investigator. Facilitates GCP, protocol adherence, patient safety, quality delivery, and customer satisfaction. Ensures compliance with PPD, sponsor, and site processes, as appropriate. Provides support with regards to site preparedness and logistics on assigned projects. Assists with site management tasks to ensure protocol, regulatory, and SOP compliance and to guarantee subject safety, data integrity, and site compliance. Travel to sites is required.

A Day in the Life:
The Assistant CRA may participate in tasks similar to the following, as delegated and supervised by the Principal Investigator:

• Data entry
• Essential document collection; regulatory and start-up activities
• Query resolution
• Chart abstraction
• Revieing patient charts to support recruitment
• Quality management and inspection readiness; identify and document protocol deviations
• Tracking biopsies
• Maintaining adequate study supplies inventory
• Supporting development of materials and tools
• Setting up electronic devices used in the study

Education

• Master’s Degree in life sciences.
• Previous clinical research experience would be an advantage.

Knowledge, Skills, Abilities

• 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 leadership skills and strong attention to detail, with a proven track record to handle multiple tasks efficiently and optimally
• Proven flexibility and adaptability
• Strong attention to detail
• 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