# Senior Clinical Research Associate

**Company**: Pfizer
**Location**: Taipei, Taiwan
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Taiwan---Taipei/Senior-Clinical-Research-Associate_4963018?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_3ca5b8ec-0fc

## Description

The Senior Clinical Research Associate is responsible for site management, site monitoring, and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution.

**Job Responsibilities**

- Responsible for investigator site management and monitoring for assigned sites:

- Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards.

- Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site initiation through to database lock.

- Serve as the primary point of contact for assigned investigator sites during study conduct.

- Interface with the study team as needed and facilitate information flow between members of the study team, vendors, and assigned investigator sites.

- Partner with SCP to perform investigator site development, coaching, and training of site personnel.

- Attend investigator meetings when required.

- Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.

- Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring, and study site closure activities.

- Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit.

- Submit all required reports, documentation, updates, and tracking within required timeframes.

- Identify and resolve investigator site issues within required timeframes.

- Resolve data queries within required timelines and prepare investigator site close-out plan.

- Clinical/Scientific and Site Monitoring Risk:

- Maintain thorough understanding of the product, protocol, and therapy area.

- Interact with investigator site healthcare professionals to enhance Pfizer's credibility and scientific leadership.

- Support the study clinician in ensuring patient safety, eligibility, and providing clinical guidance to investigators.

- Drive Quality Event remediation, when applicable.

- Other:

- Mentor/train Clinical Research Associates as assigned.

- Serve as an SME for CRA-related processes.

- Participate in regional or local working groups/process improvement initiatives.

**Qualifications**

- Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent.

- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.

- Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring.

- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

- Global clinical trial experience.

- Must be fluent in both English and Mandarin.

**Physical/Mental Requirements**

- Advanced knowledge of clinical research and development processes.

- Demonstrated knowledge of global and local regulatory requirements.

- Advanced understanding of key operational elements of clinical research.

- Proven ability to work in a matrix team environment.

- Significant travel (60-80%) within area is required.

## Skills

### Required
- clinical trial methodologies
- ICH/GCP
- FDA regulations
- Mandarin
- English

### Nice to have
- Oncology
- Vaccines
- Internal Medicine
- Infectious Diseases

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Taiwan---Taipei/Senior-Clinical-Research-Associate_4963018?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)