# Senior CRA I

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Buenos-Aires/Sr-CRA-I_265634?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ec976b1f-16e

## Description

The Senior CRA I is responsible for site monitoring and site management, ensuring clinical studies are conducted according to Fortrea and Sponsor Standard Operating Procedures and Regulatory Guidelines.

The Senior CRA I will implement project plans, lead projects of limited scope, and assume line management responsibilities as assigned.

Key responsibilities include:

- Conducting site monitoring, including routine monitoring and closeout of clinical sites

- Maintaining study files and conducting pre-study and initiation visits

- Liaising with vendors and ensuring the protection of study patients

- Verifying informed consent procedures and protocol requirements are adhered to

- Ensuring data integrity and monitoring data for missing or implausible data

- Managing travel expenses and ensuring audit readiness at the site level

- Preparing accurate and timely trip reports

- Managing small projects and serving as lead monitor for a protocol or project

- Reviewing progress and initiating actions to achieve target objectives

- Organizing and making presentations at Investigator Meetings

- Participating in protocol development and writing clinical trial reports

- Interacting with internal work groups and acting as contact for clinical trial supplies and vendors

The Senior CRA I will also be responsible for:

- Registry management

- Feasibility work

- Conducting Quality Control visits

- Recruitment of potential investigators

- Negotiating study budgets

- Tracking and following up on Serious Adverse Event reporting

- Independently performing CRF review and query generation

- Assisting with training and mentoring new employees

**Qualifications:**

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

- 3 years of clinical research experience in pharmaceutical or CRO industries

- Thorough knowledge of regulatory requirements and drug development process

- Fluent in local office language and English

**Experience:**

- 3 years of clinical monitoring experience

- Advanced site monitoring and study site management 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

**Physical Demands/Work Environment:**

- Travel requirements: 60-80% overnight

## Skills

### Required
- clinical research
- site monitoring
- study management
- regulatory guidelines
- data integrity
- communication skills

### Nice to have
- local project coordination
- project management

---

Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Buenos-Aires/Sr-CRA-I_265634?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)