Site Activation Coordinator

IQVIA; Ciudad de México; On-site; MXN 180,000 - 300,000; Full time

Job summary

IQVIA in Mexico City is seeking a site activation professional to support regulatory activities for clinical studies. Under supervision, you will perform country-level activation tasks and help maintain study documentation in accordance with SOPs, regulations and project requirements.

Responsibilities include preparing regulatory documents, informing team of document status, distributing finalized files, and updating project systems.

Qualifications

• Bachelor's degree in life sciences or related field.
• 1 year of clinical research experience as an intern or study coordinator.
• Willingness to work in the office in Mexico City.
• Good command of English.
• Strong interpersonal and organizational skills.
• Proficiency with MS Office and word processing.
• Attention to detail and understanding of the clinical trial environment.
• Ability to manage multiple projects and maintain professional relationships.

Responsibilities

• Perform site activation activities for investigative sites in assigned studies.
• Review documents for completeness, consistency and accuracy under supervision.
• Prepare site regulatory documents and inform team of document status.
• Distribute completed documents to sites and internal team members.
• Support updating and maintenance of internal systems, databases, timelines and project plans.
• Review and track progress and approval of regulatory and ethics documents.

Skills

English proficiency

Interpersonal skills

Organizational skills

Attention to detail

Multitasking

Team collaboration

Education

Bachelor's Degree Life sciences or related field

Tools

MS Office

Job description

Job Overview

Under general supervision, perform tasks at a country level associated with site activation 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, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Distribute completed documents to sites and internal project team members.
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
• 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.

Qualifications

• Bachelor's Degree Life sciences or a related field.
• 1 year of clinical research experiences as an intern or study coordinator who wants to develop in the regulatory area.
• Availability to go to the office.
• Living in Mexico City.
• Good command of English Language.
• Good interpersonal communication and organizational skills.
• Good word processing skills and knowledge of MS Office applications.
• Good attention to detail.
• General awareness clinical trial environment and drug development process.
• Ability to work on multiple projects.
• Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

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.