Clinical Research Associate II

High5; São Paulo; On-site; BRL 180,000 - 240,000; Full time

Job summary

High5 is seeking a Senior Clinical Site Monitor in São Paulo, Brazil, to ensure study sites conduct and report data per protocol, GCP, ICH, and sponsor requirements. You will lead site visits, manage recruitment plans, and provide protocol training while maintaining open communication with investigators.

The role emphasizes regulatory awareness, data quality, and collaboration with study teams to support project timelines and deliverables. Strong English skills are required.

Qualifications

• Bachelor's degree in scientific discipline or health care preferred.
• Excellent command of English (written/spoken).
• Basic knowledge of GCP/ICH guidelines and regulatory requirements.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with GCP/ICH and contracted scope.
• Drive and track subject recruitment plan to meet project needs.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Monitor regulatory submissions, recruitment, CRF completion, data queries, and ISF/TMF maintenance.

Skills

English proficiency

Attention to detail

Problem solving

Communication skills

Regulatory knowledge

MS Office

Team collaboration

Education

Bachelor's degree

Tools

MS Office

Job description

Full Time

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