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Full-time
Posted 28d ago
Apply by Sep 30
~40 hrs/week
Responsibilities
The role involves managing clinical trial administration, including document control via eTMF and site start-up activities. Additionally, the coordinator handles budgeting, contract negotiations, and financial claim management for clinical sites.
Requirements
The candidate must be able to coordinate with investigators and finance representatives to manage study budgets and legal contracts. Proficiency in clinical document archiving and adherence to financial compliance procedures is required.
Full job description
Responsibilities include, but are not limited to:
Trial and site administration:
o Track (e.g. essential documents) and report
o Ensure collation and distribution of study tools and documents
Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents, e.g. eTMF
o Assist with eTMF reconciliation
o Execute eTMF Quality Control Plan
Site Start-Up responsibilities: Collaborate with other country roles to:
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up
and submissions
o Obtain, track and update study insurance certificates
Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
o Develop, control, update and close-out country and site budgets (including Split site budget)
o Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
o Track and report contract negotiations
o Update and maintain contract templates (in cooperation with Legal Department)
o Calculate and execute payments (to investigators, vendors, grants)
o Ensure adherence to financial and compliance procedures
o Monitor and track adherence and disclosures
o Maintain tracking tools
S/AE Claim Management:
Support Financial Clinical Operation Manager(F-COM) for:
o Coordinate meetings
o Update and maintain tracking tools
o Develop and maintain settle agreements
o Coordinate for payments
o Collate, distribute/ship, and archive relevant documents
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.
Offices: 2400 Ellis Rd, Durham, North Carolina 27703, US