Assoc CRA • Monitoring

IQVIA Argentina; São Paulo; Presencial; BRL 60 000 - 120 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Senior Recruiter to join our clinical research team in São Paulo, Brazil. This program trains you to independently conduct site monitoring visits in accord with study protocol, SOPs, GCP, and regulatory requirements.

Under supervision you will manage site training, communications, and quality checks, while supporting study start-up, visit reporting, and project coordination with the study team. A strong foundation in clinical research and documentation is essential.

Qualificações

• Bachelor's degree or equivalent in life sciences or healthcare.
• Experience or understanding of clinical research is a plus.
• Familiarity with regulatory requirements (GCP/ICH) is preferred.

Responsabilidades

• Complete training to perform clinical monitoring visits per protocol and SOPs.
• Gain experience by working with experienced clinical staff.
• Under supervision, perform site monitoring visits (selection, initiation, monitoring, close-out).
• Administer protocol training to sites and maintain communication to manage expectations and issues.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, data query resolution, and TMF/ISF filing.

Conhecimentos

Strong communication skills

Attention to detail

Problem-solving

Organizational skills

Team collaboration

Formação académica

Bachelor's degree in life sciences/healthcare

Equivalent combination of education and experience

Ferramentas

Microsoft Word

Excel

PowerPoint

Descrição da oferta de emprego

Location: Brazil (Sao Paulo)

About Us: Join our team and help shape the future of our organization. We are a leading company committed to excellence and innovation, seeking a talented Senior Recruiter to support our growth.

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.

Key Responsibilities

• 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 establishes 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.

Basic Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Prior clinical experience preferred.
• 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.
• Strong attention to detail and excellent communication skills.
• Exceptional problem-solving, judgment, and decision-making abilities.
• Organizational and problem-solving 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.

Why Join Us?

• Be part of an innovative and forward-thinking company that collaborates to make a healthier world.
• Work alongside a diverse and talented team.
• Many opportunities for professional growth by developing project mgmt abilities.
• Competitive salary and benefits package.

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.