# Clinical Research Associate (CRA)

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Manila/Clinical-Research-Associate--Pooling-for-future-openings-_265731?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_5fa08828-81d

## Description

We are seeking a Clinical Research Associate (CRA) to join our team. As a CRA, you will have site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and applicable project plans 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 alongside applicable regulatory requirements

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

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

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

- Ensure adherence to global quality control and CRA performance metrics

- Ensure audit readiness at site level

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

**General On-Site Monitoring Responsibilities:**

- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study

- Perform eligibility review, verify screening, informed consent procedures, and protocol requirements are adhered to according to applicable regulatory requirements

- Ensure the integrity of the source data reported by careful source document review

- Monitor data for missing or implausible data

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

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

- Perform required monitoring tasks in an efficient manner, according to SOPs and established guidelines

- Travel, including air travel, may be required and is an essential function of the job

- Prepare and submit accurate and timely trip reports

- Independently perform eCRF review, 100% source data verification, query generation, and resolution against established data review guidelines

- Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation, and site management

- Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems

- Track IP shipments and supplies, as needed

- Track and follow-up on serious adverse events as assigned

- Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met

- Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned

- Attend investigators' meetings, project team meetings, and teleconferences, and others as needed

- Present training content for site initiation

- Assist with training of new employees

**Qualifications:**

- Minimum 2 years of site monitoring experience

- Oncology experience is required

- Experience in Start-up, site maintenance, and Close-outs

## Skills

### Required
- ICH GCP Guidelines
- Fortrea's Standard Operating Procedures
- clinical trial management
- site monitoring
- data integrity
- regulatory compliance
- oncology

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Manila/Clinical-Research-Associate--Pooling-for-future-openings-_265731?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)