Clinical Research Associate II

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

Resumo da oferta

MMC is seeking a Clinical Research Associate II to support monitoring and site management across Brazil-based studies. You will ensure sites conduct the study per protocol and regulations, maintain study data quality, and support regulatory submissions.

The role requires strong English skills, GMP/ICH knowledge, and the ability to manage multiple sites with effective communication. This is a full-time position located in Brazil with standard pharma industry benefits.

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) per scope of work and GCP/ICH guidelines.
• Work with sites to drive and track subject recruitment plans to meet project needs.
• Administer protocol and study training to sites and maintain regular communication about project expectations and issues.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate issues when needed.
• Manage study progress by tracking regulatory submissions, recruitment, CRF completion, data queries; may support start-up.
• Ensure site documents are filed in the TMF and ISF maintained per GCP/ICH and local regs.
• Create and maintain documentation on site management, visit findings, action plans and follow-ups.
• Collaborate with study team members for project execution support.

Conhecimentos

English proficiency

Attention to detail

Communication skills

Time management

Team collaboration

Problem-solving

Regulatory knowledge (GCP/ICH)

Formação académica

Bachelor's degree in science/healthcare

Ferramentas

Microsoft Word

Excel

PowerPoint

Laptop usage

Descrição da oferta de emprego

Clinical Research Associate II

( Multifully Location in Brazil ), Brazil

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

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