Sr. CRA

IQVIA Argentina; Ciudad de México; Híbrido; MXN 420.000 - 620.000; Jornada completa

Descripción de la vacante

IQVIA is seeking an experienced Clinical Research Associate to perform site monitoring and study management in Mexico City. You will ensure sites conduct the study per protocol and report data compliant with GCP/ICH and sponsor requirements.

Responsibilities include visits, recruitment tracking, training, site communications, and maintenance of TMF/ISF. Travel 8–10 times per month and strong English communication are required.

Formación

• Bachelor's Degree in a scientific field or healthcare preferred.
• Minimum 3 years of on-site monitoring experience and familiarity with GCP/ICH.
• Willingness to travel 8–10 times per month and reside in Mexico City.
• Proficient written and spoken English; strong communication skills.

Responsabilidades

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Collaborate with sites to drive recruitment and track study progress.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol compliance and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion, and data queries; support start-up if needed.
• Maintain Trial Master File and Investigator Site File in compliance with regulations.
• Document site management activities, visit findings, and action plans with reports.

Conocimientos

On-site monitoring

Travel availability

English proficiency

Communication skills

Organizational skills

Time and financial management

Relationship management

Educación

Bachelor's Degree in science or health care

Herramientas

Microsoft Word

Microsoft Excel

PowerPoint

Descripción del empleo

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• 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 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.
• 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 Scientific discipline or health care preferred.
• Requires at least 3 years of on-site monitoring experience: 4 types of monitoring visits, audits or inspections, mentoring or training new CRA´s.
• Availability to travel: 8-10 times per month.
• Living in Mexico City.
• Written and verbal communication skills including good command of English language.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• 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.