Regulatory and Start Up Specialist - Serbia

IQVIA; United States; Remote; USD 75,000 - 95,000; Full time

Job summary

IQVIA is seeking a Home Based Site Activation Specialist to coordinate startup and activation activities at the country level. You will serve as the primary point of contact for investigative sites, SAMs and the project management team, ensuring SOP compliance and timely delivery of regulatory documents.

You will maintain internal systems, review site performance metrics and support project timelines with local regulatory expertise and cross-functional collaboration.

Qualifications

• RSU/contracts experience in life sciences or clinical research preferred.
• Strong ability to act as Single Point of Contact (SPOC) for investigative sites and project teams.
• Familiarity with regulatory documents, ICFs and site activation timelines preferred.

Responsibilities

• Serve as SPOC for investigations sites, SAM, project management and other departments.
• Ensure SOPs and WIs are followed and timelines met.
• Perform startup and site activation activities per regulations and SOPs.
• Distribute documents to sites and internal teams; maintain tracking tools.
• Prepare, review and ensure completeness of site regulatory documents.

Job description

Job Overview

Perform tasks at a country level associated with Site Activation (SA) 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.

Home Based role requiring a RSU with contracts experience.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

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.