# Clinical Research Associate

**Company**: Fortrea
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Beijing/FSP-CRA-Zhengzhou-_266366?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

We are seeking a Clinical Research Associate to manage clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.

The successful candidate will be responsible for:

- Conducting site monitoring responsibilities for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits

- Preparing and implementing project plans related to Clinical Monitoring responsibilities

- Ensuring the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to

- Safeguarding data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines

- Confirming Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial

- Guaranteeing that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements

- Ensuring adherence to global quality control and CRA performance metrics

- Ensuring audit readiness at site level

- Acting in the project role of a Lead CRA as assigned

The ideal candidate will have:

- A university or college degree, or certification in a related allied health profession from an appropriately accredited institution

- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements

- Thorough knowledge of monitoring procedures

- Basic understanding of the clinical trial process

- Fluent in local office language and in English, both written and verbal

- A minimum of 2 years of Clinical Monitoring experience

- Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines

- Ability to work with minimal supervision

- Good planning, organization, and problem-solving abilities

Preferred qualifications include:

- Thorough working knowledge of Fortrea SOPs for site monitoring

- One (1) or more additional years of experience in a related field

- Phase I monitoring experience

- Life Science or Nursing qualification

- Specific skills, systems, certifications, and/or licenses

- Good attention to detail

- Methodical approach to work

- Good understanding of medical and clinical research terminology and clinical research processes

The physical demands of the job include:

- Sitting at a computer for long periods of time

- Using hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day

- Standard office and/or home working environment

- Clinical Research Unit and hospital environment (administrative only)

- Risk of eye strain

- Will involve outside of normal office hours as required by the role

- Travel Requirement is 60% of the time (travelling to study sites)

## Skills

### Required
- ICH GCP Guidelines
- Clinical Monitoring
- Source Document Review
- Data Integrity
- Regulatory Compliance

### Nice to have
- Fortrea SOPs
- Phase I monitoring
- Life Science or Nursing qualification
- e-clinical systems

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