CRA 1

IQVIA LLC; Bogotá ciudad; On-site; COP 55,000,000 - 90,000,000; Full time

Job summary

IQVIA LLC in Bogotá, Colombia is seeking a site monitoring professional to ensure studies are conducted according to protocol, GCP, ICH guidelines, and sponsor requirements. Responsibilities include site visits, subject recruitment tracking, training administration, and maintaining TMF and ISF documentation.

The role emphasizes regulatory submissions tracking, data query resolution, and collaboration with study teams; travel is required and English communication is part of the job.

Qualifications

• On-site monitoring experience or Study Coordinator experience
• Knowledge of GCP/ICH and regulatory requirements
• Proficient in MS Office and general computer skills
• Strong verbal and written English communication
• Willingness to travel and reside in Bogota, Colombia
• Organizational and problem-solving abilities

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per contracted scope and regulatory requirements (GCP/ICH)
• Track subject recruitment and adapt plans to project needs
• Administer protocol training and maintain regular communication with sites
• Evaluate site practices for protocol adherence and regulatory compliance
• Manage regulatory submissions, enrollment, CRF completion, data queries and resolutions
• Maintain TMF/ISF documentation and site files
• Submit visit reports and follow-up letters; generate required study documents
• Collaborate with study team for project execution support
• Support start-up activities and, if applicable, site financial management

Skills

English language proficiency

GCP/ICH knowledge

MS Word/Excel/PowerPoint

Organizational skills

Time management

Education

Bachelor's degree in scientific discipline or health care

Tools

Laptop/iPhone/iPad usage

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 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 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 in scientific discipline or health care preferred.
• Requires at least 1 year of on-site monitoring experience or 2-3 years as a Study Coordinator.
• Availability to Travel
• Living in Bogota, Colombia
• 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).
• 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 your interest in growing your career with us.