Associate Scientist, Laboratory Operations

IQVIA•Durham, NC

1d•$42,700 - $89,000•Onsite

About The Position

Perform routine laboratory analysis and testing procedures while supporting accurate documentation, study file maintenance, and Trial Master File delivery. Assist clinical and regulatory teams with documentation, systems updates, tracking activities, and project communications to support compliant study execution.

Requirements

High School Diploma or equivalent required
3-4 years administrative support experience
Minimum one year clinical research experience strongly preferred
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
Basic knowledge of applicable clinical research regulatory requirement, i.e., Good Clinical Practice and International Conference on Harmonization guidelines as provided in company training
Knowledge of applicable protocol requirements as provided in company training
Experience with Trial Master File maintenance, clinical documentation, Case Report Forms, queries, and clinical data flow tracking
Other equivalent combination of education, training, and experience may be accepted in lieu of degree
Written and verbal communication skills including good command of English language
Effective time management and organizational skills
Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Strong attention to detail when reviewing, filing, archiving, and maintaining study documentation
Ability to support multiple project communications, documentation workflows, and laboratory operations activities within project timelines

Responsibilities

Perform routine analysis and laboratory testing procedures to obtain data from client specimens
Provide timely documentation and review of work performed in accordance with applicable procedures
Assist Clinical Research Associates and Regulatory and Start-Up teams with updating and maintaining clinical documents and systems, including the Trial Master File
Support preparation, handling, distribution, filing, and archiving of clinical documentation and reports
Assist with periodic review of study files for completeness
Coordinate tracking and management of Case Report Forms, queries, clinical data flow, and clinical trial supplies
Serve as a central contact for designated project communications, correspondence, and associated documentation
Complete various laboratory tasks including inventory, equipment maintenance, general maintenance logs, cell culture, assay training, data compilation, and scheduling support