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0-2 years
Not Disclosed
10 Oct. 10, 2025
Job Description
Job Type: Full Time 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

Job Title:

CRA II (Clinical Research Associate II)

Location:

Taiwan – Client Site

Job ID:

25102412


Company Overview:

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into actionable outcomes.

Highlights:

  • Patient- and client-centric clinical development model

  • Collaborative, innovative, and agile work environment

  • 29,000 employees across 110 countries

  • Inclusive Total Self culture promoting authenticity and belonging


Job Summary:

CRA II is responsible for overseeing and ensuring the integrity of clinical research studies. This includes site qualification, initiation, monitoring, and close-out activities (on-site or remote). The role ensures compliance with ICH-GCP, GPP, and applicable regulations, utilizing centralized monitoring, risk-based approaches, and collaboration with site teams to improve data quality and patient safety.


Key Responsibilities:

  • Conduct site qualification, initiation, interim monitoring, management, and close-out visits

  • Evaluate site performance and staff, provide recommendations, and develop action plans

  • Verify informed consent processes and maintain patient confidentiality

  • Assess risks affecting patient safety and data integrity (protocol deviations, pharmacovigilance issues)

  • Conduct Source Document Reviews and verify CRF data accuracy

  • Apply query resolution techniques and guide site staff to ensure timely closure

  • Ensure site compliance with electronic data capture requirements

  • Manage investigational product (IP) inventory, storage, reconciliation, dispensing, and administration

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

  • Document activities via trip reports, follow-up letters, communication logs, and project documents

  • Support patient recruitment, retention, and awareness strategies

  • Track project scope, budgets, timelines, and site-level communications

  • Act as liaison with study site personnel or Central Monitoring Associate

  • Participate in Investigator Meetings, sponsor meetings, and global project staff meetings

  • Support audit readiness and follow-up actions

Additional Responsibilities for Real World Late Phase (SMA II):

  • Site support throughout the study lifecycle

  • Knowledge of local requirements for late-phase study designs

  • Chart abstraction and data collection

  • Collaborate with sponsor affiliates, medical science liaisons, and local staff

  • Train junior staff and identify out-of-scope activities

  • Suggest potential sites based on local treatment patterns, patient advocacy, and HCP networks


Qualifications:

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

  • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements

  • Strong computer skills and willingness to adopt new technologies

  • Excellent communication, presentation, and interpersonal skills

  • Ability to travel up to 75% regularly


Impact and Contribution:

  • Ensures clinical research integrity and data quality via centralized monitoring and risk-based approaches

  • Collaborates with site teams to implement tools and processes enhancing trial success

  • Acts as an individual contributor or manages small components of projects or junior staff

  • Supports patient safety, regulatory compliance, and overall clinical trial outcomes


Job Category:

Clinical Operations / Clinical Monitoring / CRA