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
Apply via :
jobs.thermofisher.com
