IQVIA Hiring Clinical Trials Assistant
IQVIA as a Clinical Trials Assistant
Job Title: Clinical Trials Assistant
Job Location: Thane, Maharashtra, India (Hybrid)
Job Overview:
As a Clinical Trials Assistant at IQVIA, your role will involve performing daily administrative activities in collaboration with Clinical Research Associates (CRAs) and the Regulatory and Start-Up (RSU) teams. You will ensure the delivery of a complete and accurate Trial Master File (TMF). Here are the essential functions of the role:
Essential Functions:
- Assist CRAs and RSU team in accurately updating and maintaining clinical documents and systems, including the Trial Master File (TMF), to track site compliance and performance within project timelines.
- Collaborate with the clinical team to prepare, handle, distribute, file, and archive clinical documentation and reports in accordance with the scope of work and standard operating procedures.
- Assist in the periodic review of study files to ensure completeness.
- Collaborate with CRAs and RSU on the preparation, handling, and distribution of Clinical Trial Supplies and the 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 project communications, correspondence, and associated documentation.
- Mentor less experienced Clinical Trial Assistants (CTAs).
- Assist in the training and onboarding of new CTAs.
- May serve as a subject matter expert for business processes.
- May lead CTA study teams.
- May assist in interviewing and screening potential new team members.
- May accompany CRAs on site visits to assist with clinical monitoring duties after completing required training.
- May participate in departmental quality or process improvement initiatives.
Qualifications:
- High School Diploma or equivalent required.
- Minimum of 2 years of administrative support experience.
- Equivalent combination of education, training, and experience.
- Minimum two years of clinical research experience is strongly preferred.
- Proficiency in computer skills, including Microsoft Word, Excel, and PowerPoint.
- Effective written and verbal communication skills, including a good command of the English language.
- Strong 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, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, as provided in company training.