# 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/Kuala-Lumpur/Clinical-Research-Associate-2_265638?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_25cd8dcb-47a

## 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.

**Responsibilities:**

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

- Prepare and implement project plans related to Clinical Monitoring responsibilities

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

- Safeguard data integrity by careful source document review, source document verification, query generation, and resolution

- Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current

- Guarantee that the study Investigational Product inventory and accountability is accurate

- Ensure adherence to global quality control and CRA performance metrics

- Ensure audit readiness at site level

- Act as a Lead CRA as assigned

**General On-Site Monitoring Responsibilities:**

- Ensure study staff have received proper materials and instructions to safely enter subjects into the study

- Perform eligibility review and verify screening, informed consent procedures, and protocol requirements

- Monitor data for missing or implausible data

- Ensure study data completeness, accuracy, consistency, and compliance

- Identify deficiencies, deviations, and discrepancies, and initiate corrective action

- Perform monitoring tasks efficiently and manage travel expenses economically

- Travel to study sites, prepare and submit trip reports, and perform eCRF review and source data verification

**Qualifications:**

- University or college degree, or certification in a related allied health profession

- Thorough understanding of ICH GCP Guidelines and local regulatory requirements

- Basic understanding of the clinical trial process

- Fluent in local office language and in English

**Experience:**

- Minimum 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

**Preferred Qualifications:**

- Thorough working knowledge of Fortrea SOPs for site monitoring

- Additional years of experience in a related field

- Phase I monitoring experience

- Life Science or Nursing qualification

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

**Physical Demands/Work Environment:**

- Must be able to sit at a computer for long periods

- Must be able to use hands to finger, handle or touch objects, tools or controls

- Standard office and/or home working environment

- Clinical Research Unit and hospital environment

- Risk of eye strain

- Will involve outside of normal office hours

- Travel Requirement is 60% of the time

## 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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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Kuala-Lumpur/Clinical-Research-Associate-2_265638?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)