IQVIA

CTA2

Sofia, Bulgaria FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“CTA 2 at IQVIA. Skills: administrative support, clinical documents and systems maintenance, documentation and report handling, tracking and management of clinical data flow, project communications. 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.. Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and”

What You'll Achieve.

ensure a complete and accurate Trial Master File delivery; track site compliance and performance within project timelines

Industry & Context.

Eligibility Requirements

May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

What They're Looking For.

Must Have

High School Diploma or equivalent, 3-4 years administrative support 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., 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.

Nice to Have

Minimum one year clinical research experience strongly preferred.

What You'll Do.

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.

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

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

and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

How You'll Work.

Team & Collaboration

in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams; Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team; Assist the clinical team; Assist CRAs and RSU; Act as a central contact for the clinical team; May accompany CRAs on site visits; May collaborate with the clinical team

Communication Scope

Written and verbal communication skills; good command of English language; project communications; correspondence

Full 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 • 3-4 years administrative support 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 c

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