Study Start-Up Clinical Research Associate Sponsor Dedicated
Study Start-Up Clinical Research Associate Sponsor Dedicated
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$ 87200 - 189000
1 Vacancy
Job Description
IQVIA is seeking Study StartUp Clinical Research Associates to join our Sponsor Dedicated teams. Ideal candidates will have experience in Study StartUp and at least 8 months of onsite monitoring experience. Candidates can be located anywhere in the United States. This role does require travel up to 7080.
Job Overview
The Study StartUp CRA is accountable for site selections as well as studyspecific startup activities and deliverables of assigned sites for Phase IIV trials in the country in accordance with monitoring procedures and processes following ICH/GCP local regulations and SOPs.
Proactive site preparation and early identification of real site needs and issues and close handover to CRA for all sites is key (from issue management to risk identification).
Supports country SSU strategy in close collaboration with the SSO Study StartUp Team Lead the SSO Study StartUp Manager and the SSO Feasibility Manager as well as the SSO Site Partnership Manager
Collaborates with the SSO Study StartUp Manager the SSO Study StartUp Team Lead and global study team to ensure Study StartUp timelines and deliverables are met according to country commitments
Accountable for timely startup activities from country allocation until site greenlight at assigned sites
Conducts site selection visits verifies site eligibility for a specific study
Acts as the main contact for trial sites during site selection study startup and IRB/IEC and HA submission preparation
Ensures that milestones (KPIs) and time schedule for study startup are met as planned
Facilitates the preparation and collection of site and country level documents
Collects submissionrelated sitespecific documents for all relevant site personnel within agreed timelines (e.g. FD CV GCP certificates DSL etc.
Supports the SSU Manager with preparation of countryspecific documents e.g. ICF patient facing materials etc.
Supports the SSO Study StartUp Manager and assigned sites with vendor setup activities
Prepares and finalizes site specific documents for submission
Negotiates investigator payments as needed
Supports preparation of financial contracts between Sponsor and investigational sites and investigators as needed
Updates all systems until site Green Light on an ongoing basis
Supports preparation of audits and inspections as applicable
Supports reduction of formal sitespecific IRB/IEC deficiencies
Ensures timelines accuracy and quality of country and site TMF documents in study startup to ensure TMF inspection readiness
Ensures adherence to financial standards prevailing legislation ICH/GCP IRB/IEC Health
Authority and SOP requirementsImplements innovative and efficient processes which are aligned with the sponsor strategy
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
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $87200.00 $189000.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.
Required Experience:
IC
Employment Type
Full-Time
