Clinical Research Regulatory Coordinator

Sayani CRO Latin America; Lima Metropolitana; Híbrido; PEN 35,000 - 50,000; Jornada completa

Descripción de la vacante

A leading Contract Research Organization in Lima is seeking a Clinical Research Regulatory Coordinator. The role involves ensuring compliance with regulatory frameworks and managing documentation for clinical research. Candidates should have a Bachelor's degree and 1-2 years of relevant experience. A hybrid work model is offered with opportunities for professional development.

Servicios

Hybrid work model

Professional development opportunities

Diverse projects

Formación

• Minimum 1-2 years in clinical research roles.
• Experience as CRA, Study Coordinator, or similar positions.

Responsabilidades

• Coordinate and manage regulatory documentation for clinical research.
• Ensure compliance with local and international regulations.
• Serve as liaison between research teams and regulatory bodies.

Conocimientos

Intermediate English

Native or fluent Spanish

Strong knowledge of ICH-GCP guidelines

Proficiency in Microsoft Office Suite

Excellent organizational skills

Strong ethical judgment

Educación

Bachelor's degree in Health Sciences or Business Administration

Diploma or Master's in Bioethics in Clinical Research

Descripción del empleo

Clinical Research Regulatory Coordinator

Clinical Research Regulatory Coordinator

SAYANI - Clinical Research Organization

Employment Type: Full-time

About SAYANI

SAYANI is a leading Contract Research Organization (CRO) supporting pharmaceutical companies and research institutions in conducting high-quality clinical trials across Latin America that meet international regulatory standards.

Position Overview

We are seeking a Clinical Research Regulatory Coordinator to join our team in Lima, Peru. This role ensures compliance with regulatory frameworks and supports scientific and administrative processes that govern clinical research conduct.

Key Responsibilities

• Coordinate and manage regulatory documentation and submissions for clinical research projects
• Ensure compliance with local and international regulations (ICH-GCP, FDA, INS, DIGEMID, etc)
• Review protocols, informed consent documents, and study-related materials
• Maintain regulatory files and documentation systems
• Coordinate meetings, reviews, and follow-up activities for research oversight
• Manage timelines and regulatory submission deadlines
• Serve as liaison between research teams, sponsors, and regulatory bodies
• Support quality oversight activities and identify compliance issues
• Communicate effectively with internal teams, investigators, and external stakeholders

Required Qualifications

Education:

• Bachelor's degree in Health Sciences (Medicine, Nursing, Pharmacy, Biology) OR Business Administration with healthcare focus
• Preferred: Diploma or Master's in Bioethics in Clinical Research

Experience:

• Minimum 1-2 years in clinical research as CRA, Study Coordinator, Clinical Trial Assistant, Regulatory Affairs Specialist, or similar roles

Skills:

• English: Intermediate level (mandatory) - reading, writing, and communication
• Spanish: Native or fluent
• Strong knowledge of ICH-GCP guidelines and regulatory requirements
• Proficiency in Microsoft Office Suite
• Excellent organizational skills and attention to detail
• Strong ethical judgment and professional integrity

What We Offer

• Hybrid work model with flexibility
• Professional development and training opportunities
• Diverse international clinical research projects
• Growth opportunities within an expanding CRO

How to Apply

Send your CV/Resume in English to:

Note: Please include your name in the subject line.