Site Activation Specialist – Regulatory & Docs

IQVIA; Ciudad de México; On-site; MXN 360,000 - 540,000; Full time

Job summary

IQVIA in Mexico City is seeking a Regulatory Site Activation Associate to support country-level activities for site initiation and maintenance under supervision. The role involves preparing regulatory documents, coordinating with the SAM and project management, and ensuring compliance with SOPs.

You should have a Life Sciences degree, 1 year of clinical research experience or internship, good English, and strong MS Office skills. This office-based role offers growth in a global CRO environment.

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.

Responsibilities

• 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.

Skills

Bachelor's degree (Life sciences)

Clinical research experience

Office-based work

English proficiency

MS Office

multitasking

Education

Bachelor's degree Life sciences or related field

Job description

IQVIA in Mexico City is seeking a Regulatory Site Activation Associate to support country-level activities for site initiation and maintenance under supervision. The role involves preparing regulatory documents, coordinating with the SAM and project management, and ensuring compliance with SOPs.

You should have a Life Sciences degree, 1 year of clinical research experience or internship, good English, and strong MS Office skills. This office-based role offers growth in a global CRO environment.