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Job Overview

Responsible for creation of Informed Consent Forms (ICF) for patients that will be later involved in clinical trials. The primary responsibility is preparation and finalization of documents for various countries and for various studies.  Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements  at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site  documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.  With moderate oversight and supervision, perform tasks at a country/region level associated with site activation activities in accordance with  applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Functions

• Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.

• With moderate oversight and supervision, serve as Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the  Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.

• Prepare site documents, reviewing for completeness and accuracy.

• Inform team members of completion of regulatory contractual. and other documents for individual sites.

• Distribute completed documents to sites and internal project team members.

• Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.

Qualifications

• Bachelor's Degree Life sciences or a related field

• 3 years’ experience in a healthcare environment or equivalent combination of education, training and experience.

• Good interpersonal communication and organizational skills. 

• Good computer skills and knowledge of MS Office applications. 

• Good attention to detail. 

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com