Senior Clinical Research Associate I - Remote Mexico

Syneos Health, Inc.; Mexico; Remote; MXN 600,000 - 800,000; Full time

Job summary

Syneos Health, Inc. in Mexico is seeking a Sr. CRA I to oversee site qualification, initiation, interim monitoring, site management and close-out visits, conducted on-site or remotely.

You will ensure regulatory, ICH-GCP and GPP compliance, assess site performance, and provide actionable recommendations to the project team to keep trials on track. The role supports informed consent processes, patient safety, source data verification, and data entry accuracy, while collaborating with sites and

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• 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.
• 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 via review of site source documents and medical records.
• 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 study 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.
• Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with project site pers

Job description

Syneos Health, Inc. in Mexico is seeking a Sr. CRA I to oversee site qualification, initiation, interim monitoring, site management and close-out visits, conducted on-site or remotely.

You will ensure regulatory, ICH-GCP and GPP compliance, assess site performance, and provide actionable recommendations to the project team to keep trials on track. The role supports informed consent processes, patient safety, source data verification, and data entry accuracy, while collaborating with sites and