Clinical Trials Assistant, Cfsp

hace 13 horas

Desde casa, México IQVIA A tiempo completo

**Job Overview** Perform daily administrative activities in collaboration with Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams to ensure the accurate delivery of the Trial Master File (TMF).

**Essential Functions**
- Assist CRAs and RSU teams with updating and maintaining clinical documents and systems (e.g., TMF) to track site compliance and performance within project timelines.
- Support 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.
- Conduct periodic reviews of study files for completeness.
- Help CRAs and RSU with the preparation, handling, and distribution of Clinical Trial Supplies and maintain tracking information.
- Track and manage Case Report Forms (CRFs), queries, and clinical data flow.
- Serve 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.

**Qualifications**
- Life science degree
- Minimum of 3 years of administrative support experience.
- ** Study Coordinator or CTA related experience is highly valued**
- Equivalent combination of education, training, and experience will be considered.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Excellent written and verbal communication skills, with a strong command of the 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, including 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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