Site Activation Specialist

IQVIA; United States; Remoto; USD 52.000 - 70.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Site Activation Specialist for a fully remote position based in Argentina. You will manage country-level SA activities, ensuring regulatory and contractual compliance and coordinating with the SAM and project teams to keep timelines on track.

The role requires a Bachelor’s degree and 2+ years in clinical research, with strong English communication and excellent organizational skills. You’ll contribute to regulatory document readiness and site performance tracking while

Competenze

• Bachelor's degree required.
• 2+ years of clinical research experience.
• Experience with Argentina regulatory activities (ethics committees, ANMAT) optional but preferred.
• Good command of English language.
• Excellent communication and organizational skills.

Mansioni

• Serve as Single Point of Contact (SPOC) for sites, SAM, PM team and others.
• Perform start-up and site activation activities per regulations and SOPs.
• Prepare site regulatory documents for completeness and accuracy.
• Maintain internal systems and tracking tools with project information.
• Provide feedback on site performance metrics to management.
• Coordinate project planning, timelines and monitoring measures.
• Inform team when regulatory and contractual documents are completed.
• Track approval and execution of regulatory, ethics, ICF, and IP release documents.
• Provide local expertise during initial and ongoing project timeline planning.
• Perform quality control of documents supplied by sites.
• May have direct contact with sponsors on specific initiatives.

Conoscenze

English proficiency

Communication skills

Organization and prioritization

Formazione

Bachelor's degree

Descrizione del lavoro

Site Activation Specialist

Full Home-based - Argentina

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.

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

• Bachelor´s degree
• 2+ years of clinical research experience, clinical trial assistant experience is a plus.
• Experience in clinical research regulatory activities in Argentina, including presentations to ethics committees and ANMAT (SSU and maintenance phases)
• Good command of English Language
• Excellent communication and interpersonal skills
• Excellent organization ad priorization skills

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.