# Experienced CRA Germany - client dedicated

**Company**: Syneos Health
**Location**: DEU-Remote
**Work arrangement**: remote
**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-Sr-CRA---Austria---client-dedicated_25113118?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_13284bf7-14f

## Description

Syneos Health is seeking an Experienced CRA Germany - client dedicated. As a member of the Clinical Solutions team, you will act with a drug development mindset, applying your years of experience and deep expertise to truly understand customer needs and represent those in the solutions you shape.

**Job Responsibilities**

- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.

- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.

- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.

- Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes.

- May perform investigational product (IP) inventory, reconciliation and reviews storage and security.

- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.

- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.

- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.

- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.

- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.

**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

- Previous monitoring experience in Germany required, in the full DACH region preferred.

- Must demonstrate good computer skills and be able to embrace new technologies

- Excellent communication, presentation and interpersonal skills

- Fluency in German and English

- Ability to manage required travel for monitoring visits in Austria, Germany and Switzerland.

**Benefits**

Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition and total rewards program.

## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- regulatory requirements
- German
- English
- computer skills

### Nice to have
- monitoring experience in Germany
- DACH region experience

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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-Sr-CRA---Austria---client-dedicated_25113118?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)