# Senior CRA I

**Company**: Fortrea
**Location**: Remote Mexico
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Remote-Mexico/Sr-CRA-I_266431?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_28e81914-ab8

## Description

We are seeking a Senior CRA I to join our team, responsible for site monitoring and site management of clinical studies according to Fortrea and Sponsor Standard Operating Procedures and Regulatory Guidelines.

The Senior CRA I will assure the implementation of project plans, function as a leader for projects of limited scope, and assume line management responsibilities as assigned.

**Responsibilities:**

- Conduct site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, and conduct of pre-study and initiation visits

- Manage site management as prescribed in project plans

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

- Verify informed consent procedures and protocol requirements are adhered to according to regulatory requirements

- Review data for missing or implausible data and ensure data integrity

- Monitor data for missing or implausible data and ensure audit readiness at the site level

- Travel, including air travel, may be required (60-80% overnight)

- Prepare accurate and timely trip reports

- Manage small projects under the direction of a Project Manager/Director

- Serve as lead monitor for a protocol or project and assist in establishing monitoring plans

- Review progress of projects and initiate actions to achieve target objectives

- Organize and make presentations at Investigator Meetings

- Participate in protocol development and writing clinical trial reports

- Interact with internal work groups to evaluate needs, resources, and timelines

- Act as contact for clinical trial supplies and other suppliers

- Responsible for registry management as prescribed in project plans

- Undertake feasibility work and conduct Quality Control visits

- Recruit potential investigators, prepare EC submissions, and notify regulatory authorities

- Negotiate study budgets with potential investigators and assist with statements of agreements

- Track and follow-up on Serious Adverse Event reporting

- Independently perform CRF review and query generation and resolution

- Assist with training and development of new employees

- Coordinate designated clinical projects as a Local Project Coordinator

**Qualifications:**

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

- Three years of Clinical Monitoring experience

- Thorough knowledge of regulatory requirements and drug development process

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

- Advanced site monitoring, study site management, and registry administration skills

- Ability to work with minimal supervision and good planning and organization skills

- Good computer skills and advanced verbal and written communication skills

- Ability to train and supervise junior staff and resolve project-related problems

- Valid Driver's License

**Preferred Qualifications:**

- Additional experience in a related field (e.g., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management, or technical writing)

- Local project coordination and/or project management experience

## Skills

### Required
- clinical research
- site monitoring
- regulatory guidelines
- study management
- data analysis
- communication
- project management

### Nice to have
- local project coordination
- medical
- clinical
- pharmaceutical
- laboratory
- research
- data management
- technical writing

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Remote-Mexico/Sr-CRA-I_266431?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)