Coordinating CRA

IQVIA; São Paulo; On-site; BRL 120,000 - 180,000; Full time

Job summary

IQVIA is seeking an experienced Clinical Research Associate to perform site monitoring and management across protocols and therapeutic areas. The role involves on-site activities, documentation, and collaboration with study teams in Brazil and beyond.

You will oversee site initiation, monitoring, and close-out visits, drive recruitment plans, train site staff, and ensure compliance with GCP/ICH guidelines. Strong communication and organizational skills are essential.

Qualifications

• Bachelor's degree in science or health care required.
• Minimum 5 years of on-site monitoring experience; at least 1 year as a SR CRA.
• Strong knowledge of GCP/ICH guidelines and regulatory requirements.
• Excellent communication and time-management skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and regulatory requirements.
• Drive subject recruitment plans with sites to support project needs.
• Train sites on protocol and study procedures; maintain regular communication.
• Assess quality/ integrity of site practices and raise issues as needed.
• Track regulatory submissions, recruitment, CRFs, data queries; may support start-up.
• Maintain TMF/ISF documentation and generate visit reports and follow-up letters.
• Mentor clinical staff via co-monitoring and training visits.
• Collaborate with study team; support site financial management when applicable.

Skills

Site monitoring

GCP/ICH knowledge

Regulatory compliance

English proficiency

Communication

Time management

Excel

PowerPoint

Education

Bachelor's degree in life sciences or health care

Tools

Excel

PowerPoint

Laptop/Mobile tools

Job description

Mexico City, Mexico

São Paulo, Brazil

Full time

R1573059

Job Overview

Perform monitoring and site management work for a variety of protocols, site and therapeutic areas.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 5 years of year of on-site monitoring experience, MINIMUM 1 year as a SR CRA.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Strong computer skills: Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for growing your career with us.

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