Study Start up Specialist, IQVIA Biotech

IQVIA; São Paulo; On-site; BRL 80,000 - 120,000; Full time

Job summary

IQVIA in São Paulo, Brazil is seeking a Site Activation Coordinator to perform country-level SA activities under regulatory SOPs and project requirements. You will manage documentation and ensure accuracy while coordinating with cross-functional teams to meet timelines.

The role emphasizes precise regulatory documentation, adherence to SOPs, and collaboration with Site Activation Managers and project teams.

Qualifications

• At least 1 year of clinical research experience.
• Site activation US and CAN ICF review experience is required.
• Experience adapting country ICF for US/Canada regulatory requirements preferred.
• Experience reviewing informed consent elements using checklists.
• Ability to work with cross-functional teams and meet timelines.

Responsibilities

• Act as Single Point of Contact (SPOC) for investigative sites and project teams.
• Perform site activation activities and distribute documents.
• Prepare site regulatory documents and review for completeness.
• Maintain internal systems and project tracking tools.
• Review site performance metrics and participate in planning.
• Coordinate project timelines and contingency planning.
• Inform team of regulatory and contract document completion.
• Track and follow up on approvals and IP/IP release.
• Provide local expertise to SAMs and project teams.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on initiatives.

Skills

Clinical research

Site activation

ICF review

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.

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.

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.

Qualifications

• 1 year clinical research experience. Equivalent combination of education, training and experience.

• Site activation US and CAN ICF review experience is required.
• Experience in adapting a country ICF for US and Canada regulatory requirements is preferred, but not required.
• Experience reviewing information consents for elements of consent using a checklist, site specific ICF and central IRB ICFs. Both site activation ICF and for revised ICF in study maintenance

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.