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Sr Cra I (Full Service Single Sponsor Dedicated)

0-2 years
Not Disclosed
10 Jan. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Senior Clinical Research Associate I (Full Service, Single Sponsor Dedicated)
Location: Taipei, Taiwan (Greater China), Asia Pacific
Job ID: 25001205


Job Description

Syneos Health®, a leading biopharmaceutical solutions organization, is seeking a Senior Clinical Research Associate I to join their team in a full-service, single-sponsor capacity. This role supports the clinical development process, ensuring regulatory compliance and contributing to high-quality clinical trials.


Key Responsibilities

Clinical Site Monitoring and Compliance

  • Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely) following regulatory, ICH-GCP, and protocol guidelines.
  • Ensure informed consent is obtained, documented, and confidentiality is maintained.
  • Identify protocol deviations, safety concerns, and pharmacovigilance issues, escalating them appropriately.

Data and Documentation Management

  • Perform source document review to ensure data accuracy in case report forms (CRFs).
  • Resolve data queries on-site or remotely and provide guidance to site staff.
  • Verify investigational product (IP) inventory, storage, and compliance with protocol requirements.
  • Maintain the Investigator Site File (ISF) and reconcile it with the Trial Master File (TMF).

Project and Site-Level Responsibilities

  • Understand project scope, budgets, and timelines, ensuring deliverables are met.
  • Serve as a liaison between site personnel, project teams, and Central Monitoring Associates.
  • Prepare confirmation letters, trip reports, and other required documentation.

Training and Mentorship

  • Mentor junior CRAs, conduct training sessions, and provide operational guidance.
  • Participate in and potentially lead global project staff meetings.

Real World Late Phase (RWLP) Studies

  • Support chart abstraction, patient recruitment, and data collection.
  • Collaborate with local affiliates, medical liaisons, and regulatory teams.
  • Contribute to country-level informed consent development and regulatory updates.

Qualifications

Education and Experience

  • 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 regulatory requirements.

Skills and Competencies

  • Strong computer skills and adaptability to new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Critical thinking skills and ability to manage priorities in a dynamic environment.
  • Willingness to travel up to 75%.

Why Syneos Health

  • Work in a Total Self Culture that fosters diversity, authenticity, and belonging.
  • Join a global organization involved in 94% of all Novel FDA Approved Drugs in the past 5 years.
  • Collaborate with innovative teams driving the delivery of therapies that change lives.

Additional Information:
This job description outlines primary tasks but is not exhaustive. Syneos Health reserves the right to assign other responsibilities as needed. We are an equal opportunity employer committed to diversity and inclusion.