CRA II - SR CRA Brazil

Syneos Health, Inc.; Brasil; Presencial; BRL 70 000 - 100 000; Tempo integral

Resumo da oferta

Syneos Health, Inc. is looking for a CRA II in Brazil to ensure compliance during clinical studies through both on-site and remote monitoring. This role involves site qualification, monitoring, and evaluation of staff performance while maintaining adherence to regulatory standards.

Ideal candidates should possess a Bachelor's degree or RN and be knowledgeable in Good Clinical Practice guidelines. Strong communication skills and the ability to travel frequently are essential.

Qualificações

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
• Ability to travel up to 75% on a regular basis.

Responsabilidades

• Perform site qualification, initiation, interim monitoring, site management, and close-out visits.
• Evaluate site and staff performance and communicate serious issues to the project team.
• Verify informed consent and assess factors affecting subject safety and data integrity.
• Conduct source document review and verify CRF data accuracy.
• Manage project scope, budgets, and timelines.

Conhecimentos

Good Clinical Practice/ICH Knowledge

Communication skills

Critical thinking

Computer skills

Interpersonal skills

Presentation skills

Formação académica

Bachelor’s degree or RN in a related field

Descrição da oferta de emprego

Overview

CRA II - SR CRA Brazil. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Discover what our 29,000 employees, across 110 countries already know.

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Diversity of thoughts, backgrounds, cultures, and perspectives helps everyone belong.

Summary and role context: Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical studies to ensure trials are conducted in accordance with clinical practices, including on-site and remote monitoring, and development of tools and processes to ensure quality monitoring.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Evaluates site and staff performance and provides recommendations; communicates/escalates serious issues to the project team and develops action plans. Maintains knowledge of ICH/GCP Guidelines and applicable regulations and SOPs.
• Verifies informed consent is obtained and documented; protects confidentiality; assesses factors affecting subject safety and data integrity at investigator sites (e.g., protocol deviations and pharmacovigilance issues).
• According to CMP/SMP: assesses site processes; conducts source document review; verifies CRF data accuracy via source documents and medical records. Applies remote and on-site query resolution; guides site staff to closure within timelines. Uses hardware/software to support data review and capture; verifies site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and storage/security reviews. Verifies IP dispensing per protocol; ensures proper labeling, import, release/return and handling of blinded or randomized IP.
• Routinely reviews Investigator Site File (ISF) accuracy and timeliness; reconciles ISF with TMF; ensures archiving of essential documents per local guidelines and regulations.
• Documents activities via letters, reports, logs, and other project documents; supports recruitment, retention and awareness strategies; enters data into tracking systems to monitor observations, status and actions to resolution.
• Manages project scope, budgets and timelines for own and others’ activities; adapts to changing priorities to meet goals.
• May act as primary liaison with study site personnel or with Central Monitoring Associate; ensures training and compliance of site team members.
• Prepares for and attends Investigator Meetings; may lead global clinical monitoring/project staff meetings and attends clinical training sessions.
• Provides guidance toward audit readiness and supports audit preparation and follow-up actions.
• May supervise, train and mentor junior CRAs; may participate in business development proposals and defense meetings.
• For Real World Late Phase (RWLP), additional responsibilities include site support through the study lifecycle, chart abstraction and data collection, collaboration with Sponsor and affiliates, training junior staff, identifying out-of-scope activities, proposing site opportunities, process improvements, and involvement in RFPs and case report form design.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements
• Good computer skills and ability to adapt to new technologies
• Excellent communication, presentation and interpersonal skills; moderate critical thinking
• Ability to travel up to 75% on a regular basis

We are always excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role. By expressing your interest, you’ll be added to our talent pipeline and considered should this role become available.

Get to know Syneos Health

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require reasonable accommodation to complete any part of our application process, contact us at [e-mail].

Summary: Roles within Clinical Monitoring/CRA monitor trials to ensure compliance with clinical practices, including on-site and remote monitoring, and the development of processes for quality monitoring.

Website: http://www.syneoshealth.com