Clinical Country & Site Associate – Clinical Trial Manager

Syneos Health

Clinical Country & Site Associate managing clinical trial sites in Brazil. Ensures compliance with regulatory standards during site monitoring and management activities.

Posted 7/2/2026full-timeRemote • 🇧🇷 BrazilJuniorMid-LevelWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
Demonstrates diligence in protecting the confidentiality of each subject/patient.
Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes
Conducts Source Document Review of appropriate site source documents and medical records
Verifies required clinical data entered in the case report form (CRF) is accurate and complete
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
Verifies site compliance with electronic data capture requirements.
May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
Verifies issues or risks associated with blinded or randomized information related to IP.
Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
Reconciles contents of the ISF with the Trial Master File (TMF).
Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
Supports subject/patient recruitment, retention and awareness strategies.
Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

Requirements

What you’ll need

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 applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills
Ability to manage required travel of up to 75% on a regular basis.

Benefits

Comp & perks

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 building an inclusive culture – where you can authentically be yourself.

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Site QualificationSource Document ReviewClinical Data EntryQuery Resolution TechniquesInformed Consent VerificationInvestigational Product ManagementRegulatory ComplianceClinical MonitoringData Capture RequirementsTrial Master File Reconciliation

Soft Skills

Excellent CommunicationPresentation SkillsInterpersonal Skills

Certifications

Bachelor’s DegreeRegistered Nurse (RN)