# Senior Clinical Research Associate II (Sr CRA II)

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Seoul/Senior-CRA-FSP-model_266364?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_03ee5795-281

## Description

We are seeking a Senior Clinical Research Associate II (Sr CRA II) to join our team. As a Sr CRA II, you will be responsible for site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.

**Responsibilities:**

- Conduct site monitoring and site management for clinical studies

- Ensure implementation of project plans and function as leader for projects of limited scope

- Manage study site monitoring, including routine monitoring and close-out of clinical sites

- Maintain study files and conduct pre-study and initiation visits

- Liaise with vendors and perform other duties as assigned

- 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

- Monitor data for missing or implausible data

- Ensure audit readiness at the site level

- Travel may be required, including air travel

- 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

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

- Organize and make presentations at Investigator Meetings

- Participate in development of protocols and Case Report Forms

- Participate in 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

- Undertake feasibility work and conduct Quality Control visits

- Recruit potential investigators and prepare EC submissions

- Negotiate study budgets with potential investigators

- Track and follow-up on Serious Adverse Event (SAE) reporting

- Independently perform CRF review and query generation and resolution

- Assist with training and mentoring of new employees

- Coordinate designated clinical projects as a Local Project Coordinator

**Qualifications:**

- University or college degree in a related allied health profession

- Certification in a related allied health profession (e.g., nursing licensure)

- Equivalent amount of experience can be substituted as appropriate

- Thorough knowledge of regulatory requirements and drug development process

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

- Three-Four years of Clinical Monitoring experience

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

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

- Good computer skills with good working knowledge of a range of computer packages

- Advanced verbal and written communication skills

- Ability to train and supervise junior staff

**Preferred Qualifications:**

- Thorough knowledge of company SOPs regarding site monitoring

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

- Local project coordination and/or project management experience

- Ability to maintain confidentiality of data and information

- Demonstrated ability to conduct clinical operations activities effectively and efficiently

- Methodical approach to work and strong understanding of medical and clinical research terminology

## Skills

### Required
- Clinical Monitoring
- Site Management
- Regulatory Requirements
- Drug Development Process
- English

### Nice to have
- Clinical Operations
- Project Management
- Registry Administration
- Quality Control
- Clinical Trial Management System (CTMS)

---

Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Seoul/Senior-CRA-FSP-model_266364?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)