Clinical Trial Documentation & Compliance Assistant

IQVIA; Carlsbad (CA); On-site; USD 36,000 - 123,000; Full time

Job summary

IQVIA is seeking an administrative support professional in Carlsbad, CA to assist Clinical Research Associates and the Regulatory/Start-Up team with updating and maintaining clinical documents and TMF systems. This role supports study teams, tracks site compliance, and helps ensure project timelines are met.

The position requires a Bachelor’s degree and 3 years of admin experience, plus proficiency with Word, Excel and PowerPoint.

Qualifications

• Bachelor's Degree required.
• 3 years administrative support experience.
• Equivalent combination of education, training and experience.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• 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.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

Responsibilities

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Skills

Communication skills

Time management

Organizational skills

English proficiency

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

IQVIA is seeking an administrative support professional in Carlsbad, CA to assist Clinical Research Associates and the Regulatory/Start-Up team with updating and maintaining clinical documents and TMF systems. This role supports study teams, tracks site compliance, and helps ensure project timelines are met.

The position requires a Bachelor’s degree and 3 years of admin experience, plus proficiency with Word, Excel and PowerPoint.