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    Clinical Trail Assistant

    Iqvia
    0-3 years
    Not Disclosed
    Bengaluru
    10 Feb. 27, 2024
    Job Description
    Job Type: Full Time Education: Any Graduate Skills: Communication Skills, Interpersonal Skill, Technical Skill

    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.
    • Collaborate with 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.
    • Assist with periodic review of study files and completeness.
    • Collaborate with CRAs and RSU on the 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.
    • Act as a mentor for less experienced Clinical Trial Assistants (CTAs).
    • Assist with training and onboarding of new CTAs.
    • May serve as subject matter expert for business processes.
    • May lead CTA study teams.
    • May assist with interviewing and screening of potential new team members
    • May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
    • May participate in departmental quality or process improvement initiatives.

    Qualifications:

    • High School Diploma or equivalent Req
    • 5 administrative support experience.
    • Equivalent combination of education, training and experience.
    • Minimum two years clinical research experience strongly preferred.
    • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
    • Effective 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.
    • Knowledge 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.

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