Sr CRA FSP - Sponsor Dedicated

IQVIA; Estado de México; On-site; MXN 600,000 - 900,000; Full time

Job summary

IQVIA in Mexico is seeking a Clinical Research Associate to perform monitoring and site management to ensure protocol compliance, data quality and regulatory adherence across study sites.

The role requires at least 4 years of on-site monitoring, experience in Phase III and cardiovascular trials, travel as needed, and proficiency with MS Word, Excel and PowerPoint, plus strong English communication.

Qualifications

• Bachelor's Degree in a scientific discipline or health care is preferred.
• Requires at least 4 years of on-site monitoring experience with sites.
• Experience in Phase III clinical trials and cardiovascular therapeutic area.
• Willingness to travel and go to the office once per week.
• Good knowledge of GCP/ICH guidelines and regulatory requirements.
• Proficient in Word, Excel and PowerPoint; good English communication.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out).
• Coordinate recruitment plans and track subject enrollment as needed.
• Administer protocol training to sites and maintain communications.
• Evaluate site practices for protocol compliance and regulatory adherence.
• Track regulatory submissions, approvals, CRF completion and data queries.
• Maintain TMF/ISF documentation and generate regular visit reports.

Skills

Site monitoring

Travel readiness

GCP knowledge

Communication skills

Education

Bachelor's degree in scientific field 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.

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.

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.