Clinical Trial Assistant 2- Sofia- Hybrid

IQVIA; United States; Remote; USD 45,000 - 65,000; Full time

Job summary

A leading global provider of clinical research services seeks to fill a position that supports the Clinical Research Associates and Regulatory teams. This role involves managing clinical documentation and ensuring compliance while enhancing patient outcomes and population health through innovative medical treatments.

Qualifications

• Minimum of 2 years of equivalent experience in clinical research.
• Knowledge of GCP and ICH guidelines preferred.
• Effective communication skills in English, both written and verbal.

Responsibilities

• Assist with updating and maintaining clinical documents.
• Coordinate tracking and management of Case Report Forms (CRFs).
• Act as a central contact for project communications.

Skills

Time Management

Organizational Skills

Communication

Education

High School Diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job Overview

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

• 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. Coordinate 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.
• May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Qualifications

• High School Diploma or equivalent Req
• 2 years plus of pervious equivalent experience
• r Equivalent combination of education, training and experience.
• Minimum one year clinical research experience strongly preferred.
• 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.
• Basic knowledge of applicable clinical research regulatory requirement, 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com