Sr CRA FSP - Sponsor Dedicated

MSC Quintiles Mexico S. de R.L. de C.V.; Ciudad de México; On-site; MXN 600,000 - 900,000; Full time

Job summary

IQVIA Inc is seeking an experienced Clinical Research Monitor in Mexico City to ensure sites conduct studies per protocol and regulatory guidelines. You will monitor sites, manage recruitment plans, train site staff, and maintain essential study documentation with regular communication to the study team.

The role requires 4+ years of on-site monitoring, travel flexibility, and strong English communication. Knowledge of GCP/ICH and regulatory standards is essential.

Qualifications

• Bachelor's degree in a scientific or health-related field is preferred.
• Minimum 4 years of on-site monitoring experience with site visits and monitoring reports.
• Experience in clinical phase III and cardiovascular therapeutic area is desirable.
• Ability to travel and visit the office once per week.
• Solid knowledge of GCP, ICH guidelines and regulatory requirements.
• Proficiency with MS Word/Excel/PowerPoint and basic IT equipment.
• Strong written and spoken English communication, organizational and problem-solving skills.

Responsibilities

• Perform monitoring visits (initiation, ongoing, close-out) per contract scope and GCP.
• Collaborate with sites to drive subject recruitment plans and predictability.
• Administer protocol training and establish regular site communication.
• Assess site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, data queries, and resolutions.
• Maintain Trial Master File and Investigator Site File documentation.
• Generate visit reports, follow-up letters, and study documentation.
• Coordinate with study team for project execution and support startup activities.
• Support development of recruitment plans per site and assist site finance as needed.

Skills

On-site monitoring

Clinical trial management

GCP/ICH knowledge

Regulatory requirements

Travel flexibility

English communication

MS Word

MS Excel

MS PowerPoint

Education

Bachelor's Degree in scientific discipline or healthcare

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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 (concluded).
• Requires at 4 years of on-site monitoring experience: working with sites, onsite monitoring visits, preparation of monitoring reports, working with public sites.
• Experience in clinical phase III & Cardiovascular Therapeutic Area.
• Availabitlity to Travel & go to office once per week.
• 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).
• 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.

About IQVIA

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 your interest in growing your career with us.