# CRA II (client dedicated)

**Company**: Syneos Health
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/DEU-Remote/CRA-II--client-dedicated-_25113082?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_03423ebd-30e

## Description

Syneos Health is seeking an experienced CRA to join their team. As a CRA II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits. You will ensure regulatory, ICH-GCP, and protocol compliance, and use your judgment and experience to evaluate site performance and provide recommendations.

Responsibilities:

- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits

- Ensure regulatory, ICH-GCP, and protocol compliance

- Evaluate site performance and provide recommendations

- Verify informed consent process and document confidentiality

- Assess site processes and conduct source document reviews

- Apply query resolution techniques and provide guidance to site staff

- Manage investigational product inventory and reconciliation

- Review Investigator Site File and reconcile contents with Trial Master File

- Document activities and support subject recruitment and retention

- Understand project scope, budgets, and timelines

- Adapt to changing priorities and achieve goals

- Act as primary liaison with study site personnel

- Prepare for and attend Investigator Meetings and sponsor face-to-face meetings

- Provide guidance on audit readiness standards

Qualifications:

- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience

- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

- Good computer skills and ability to adapt to new technologies

- Fluency in German and English

- Excellent communication, presentation, and interpersonal skills

- Location in South-West Germany, with ability to support Swiss sites

- Ability to manage required travel of up to 75% on a regular basis

## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- regulatory compliance
- site management
- clinical monitoring
- German
- English

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/DEU-Remote/CRA-II--client-dedicated-_25113082?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)