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0-2 years
Not Disclosed
10 Oct. 10, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

CRA II – Clinical Research Associate

Updated: Yesterday
Location: MEX-Remote
Job ID: 25102282


Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

Our Clinical Development model centers on the customer and patient. We continuously streamline processes to make Syneos Health easier to work with and a better place to work.

Whether in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help customers achieve their goals.

WORK HERE MATTERS EVERYWHERE


Why Syneos Health

  • Career development and progression opportunities.

  • Supportive and engaged line management.

  • Technical and therapeutic area training.

  • Peer recognition and total rewards program.

  • Inclusive Total Self culture encouraging authenticity.

  • Diversity of thoughts, backgrounds, and perspectives ensures everyone belongs.


Job Responsibilities

Clinical Monitoring & Site Management

  • Perform site qualification, initiation, interim monitoring, management, and close-out visits (onsite or remote) ensuring compliance with ICH-GCP, GPP, and protocol.

  • Evaluate site performance and recommend site-specific actions. Escalate serious issues to the project team.

  • Verify proper informed consent documentation and protect patient confidentiality.

  • Assess factors affecting patient safety and clinical data integrity (protocol deviations, PV issues).

Data & Documentation

  • Conduct source document review (SDR) to verify clinical data accuracy in CRFs.

  • Apply query resolution techniques and guide site staff.

  • Manage investigational product (IP) inventory, reconciliation, and administration compliance.

  • Review and reconcile Investigator Site Files (ISF) with Trial Master File (TMF).

  • Document activities (letters, reports, communication logs) per SOPs.

  • Track observations, ongoing status, and action items to resolution.

Project & Site Support

  • Understand project scope, budgets, and timelines; manage site-level activities to ensure objectives are met.

  • Act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate.

  • Prepare for and attend investigator and sponsor meetings, clinical staff meetings, and training sessions.

  • Support audit readiness and preparation for site audits.

  • For Real World Late Phase studies, perform site support from identification to close-out, chart abstraction, and local regulatory compliance.

  • Train junior staff as required and communicate out-of-scope activities to Lead CRA/Project Manager.


Qualifications

  • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.

  • Knowledge of Good Clinical Practice (GCP) / ICH Guidelines and regulatory requirements.

  • Strong computer literacy and ability to adopt new technologies.

  • Excellent communication, presentation, and interpersonal skills.

  • Ability to manage travel up to 75% regularly.

  • U.S. ONLY: Compliance with site-specific requirements for facility access may be required.


Get to Know Syneos Health

  • Worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products over the past 5 years.

  • Supported over 200 studies across 73,000 sites and 675,000+ trial patients.

  • Encourages initiative and challenges the status quo in a competitive environment.

Learn more: Syneos Health


Additional Information

  • Job duties may change at the company's discretion.

  • Equivalent experience or skills may be considered.

  • No part of this description creates an employment contract.

  • Company complies with local and international employment legislation.

  • Reasonable accommodations provided per the Americans with Disabilities Act.


Summary

CRA II roles are responsible for overseeing clinical research studies remotely, ensuring compliance with regulations and protocols, monitoring trial sites, and supporting quality data capture. They collaborate with site teams to enhance monitoring and contribute to the success of clinical trials.