Job Responsibilities :
Assist Clinical Research Specialist (CRS) / In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs) / In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
Collaborate with Clinical Project Manager (CPM), CRS / iCRS, CRAs / iCRAs and RSU 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 CRS / iCRS, CRAs / iCRAs 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.
Assist in training and orienting new staff. May act as a mentor for less experienced CTAs
May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
Perform assigned administrative tasks to support team members with clinical trial execution.
Job Requirements :
Bachelors Degree in Pharmaceutical or related field
Min. 2 - 3 years of experience in clinical research environment
Open to candidates from non-clinical research environment but strong experience in administrative duties
Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Broad knowledge of applicable protocol requirements as provided in company training
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
Good 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
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
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