Coordinating CRA

IQVIA; Ciudad de México; On-site; MXN 450,000 - 750,000; Full time

Job summary

IQVIA in Ciudad de México is seeking an experienced Clinical Research Associate to perform monitoring and site management across multiple protocols and therapeutic areas. You will ensure GCP/ICH compliance and data integrity at each site.

Responsibilities include conducting monitoring visits, supporting recruitment plans, training site staff, managing TMF/ISF, and mentoring clinical personnel to drive project success while safeguarding patient safety.

Qualifications

• Bachelor's degree in scientific discipline or health care preferred.
• Requires at least 5 years of on-site monitoring experience, MINIMUM 1 year as a SR CRA.
• In depth knowledge of GCP and ICH guidelines.
• Strong protocol knowledge as provided in company training.
• Strong computer skills: Excel and PowerPoint.
• Written and verbal communication skills including good command of English.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits).
• Work with sites to drive and track subject recruitment plans.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion and data queries.
• Ensure TMF/ISF documents are filed and maintained.
• Create and maintain documentation of site management and visit findings.
• Mentor clinical staff including co-monitoring and training visits.
• Collaborate with study team for project execution and support recruitment planning.
• May support startup activities and site financial management where applicable.

Skills

On-site monitoring

GCP/ICH knowledge

English proficiency

Excel & PowerPoint

Communication

Time management

Team collaboration

Regulatory familiarity

Education

Bachelor's degree in science/healthcare

Tools

Microsoft Excel

PowerPoint

Job description

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.