Assoc CRA - CRA School

ARG IQVIA RDS Argentina SRL; Ciudad Autónoma de Buenos Aires; Presencial; ARS 1.500.000 - 6.500.000; Jornada completa

Descripción de la vacante

A leading clinical research organization in Buenos Aires is seeking a Clinical Monitor to participate in a structured training program. You will conduct monitoring visits, oversee study procedures, and ensure adherence to protocols and regulations. The ideal candidate holds a Bachelor's Degree in a scientific discipline or health care and possesses strong communication and organizational skills. Clinical experience is preferred, and availability for travel is required.

Formación

• Ability to travel as needed.
• Prior clinical experience preferred.
• Advanced knowledge of GCP and ICH guidelines.

Responsabilidades

• Conduct clinical monitoring visits as per guidelines.
• Administer training to study sites under supervision.
• Evaluate study site practices for protocol adherence.
• Track study progress including regulatory submissions.

Conocimientos

Verbal communication skills

Written communication skills

Organizational skills

Problem-solving skills

Time management skills

Financial management skills

Educación

Bachelor's Degree in scientific discipline or health care

Monitoring course completed

Herramientas

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

iPhone

iPad

Descripción del empleo

Job Overview

Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

Essential Functions

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
• Gain experience in study procedures by working with experienced clinical staff.
• Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
• Under close supervision, administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Under close supervision, 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.
• Under close supervision, 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 Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements.
• Under close supervision may support start-up phase.
• Under close supervision, 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, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress.

Qualifications

• Bachelor\'s Degree in scientific discipline or health care (Required)
• Monitoring course completed (Pref)
• Based in Buenos Aires (CABA / GBA)
• Availability to travel
• Written and verbal communication skills including good command of English language.
• Prior clinical experience preferred.
• Some organizations may require 2 years of clinical experience.
• 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.
• Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Knowledge of applicable protocol requirements as provided in company training.