# Clinical Research Coordinator

**Company**: Fortrea
**Location**: Mexico City
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Mexico-City/Start-up-Specialist_264439?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_89d8cb3d-127

## Description

We are seeking a Clinical Research Coordinator to serve as primary contact with investigative site(s) during site start-up activities and maintenance.

The successful candidate will be responsible for collecting required investigator and essential documents for a study, ensuring EC/IRB/Third body/Regulatory Authority and local applications are made within agreed timelines.

**Responsibilities:**

- Maintain awareness of regulatory legislation, guidance, and practice in assigned countries

- Coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authority

- Compile and prepare routine submissions filed to IRB/IEC/Third body/Regulatory Authorities

- Liaise with internal and external vendors in generating Regulatory Authority submissions

- Perform a review of final submission documents

- Ensure assigned start-up and maintenance activities are on track, in accordance with client expectations and budget, and in compliance with applicable laws and guidelines

- Prevent and escalate study issues appropriately and in a timely fashion

- Perform other duties as assigned by management

**In-country specific tasks:**

- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner

- Collect and track necessary documents required and perform a quality review, formatting, and compilation of final documents for site activation and maintenance

- Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis

- Participate in team and project meetings as applicable

- Assist in strategy definition for Site Activation and provide accurate projections and timelines to study teams

- Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol

- May support negotiation of site contracts and budgets with sites

- Proactively identify and escalate risks to meeting deliverables

**Clinical Trials Information System (CTIS) tasks:**

- Assist in uploading submission documentation to CTIS and interact with and monitor notifications and alerts

- Perform other duties as needed or assigned

**Qualifications:**

- University/College degree (life science preferred) or certification in a related allied health profession

- 2 years' work experience in clinical research, including a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations

**Experience:**

- Minimum of 2 years of experience in clinical development or start-up/regulatory process

- Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines

- Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them

## Skills

### Required
- ICH guidelines
- RA regulations
- IRB/IEC regulations
- clinical research
- clinical development

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Mexico-City/Start-up-Specialist_264439?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)