CRA 1

IQVIA; São Paulo; Presencial; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Senior Recruiter to support clinical studies with site monitoring and regulatory compliance responsibilities. The role involves coordinating site visits, managing recruitment plans, and ensuring proper study documentation.

Ideal candidates will have a scientific or healthcare degree, excellent English, and familiarity with GCP/ICH guidelines. Strong communication and organizational skills are essential for success in a fast-paced, global team.

Qualificações

• Bachelor's Degree in scientific discipline or health care preferred.
• Excellent command of English (written/spoken).
• Basic knowledge of applicable clinical research regulatory requirements (GCP/ICH).
• Good therapeutic and protocol knowledge as provided in company training.

Responsabilidades

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with scope of work and regulatory requirements (GCP/ICH).
• Work with sites to adapt, drive and track subject recruitment plan to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular communication with sites.
• Evaluate quality and integrity of site practices related to protocol and regulations; escalate issues as appropriate.
• Manage progress of assigned studies by tracking regulatory submissions, recruitment, CRF completion, data queries; may support start-up phase.
• Ensure site documents are available for TMF filing and ISF maintained per GCP/ICH and local regulations.
• Create and maintain documentation on site management, monitoring findings, and action plans; submit visit reports and follow-up letters.
• Collaborate with study team members for project execution support.

Conhecimentos

Excellent English

GCP/ICH knowledge

Regulatory knowledge

Formação académica

Bachelor's Degree in scientific discipline or health care

Ferramentas

MS Word

MS 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: 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.

Key Responsibilities

• 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) 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.
• Collaborate and liaise with study team members for project execution support as appropriate.

Basic Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred.
• Excellent command of English (written/spoken).
• Basic 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.

Others Requirements

• Strong attention to detail and excellent communication skills.
• Exceptional problem-solving, judgment, and decision-making abilities.
• 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.

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.