# Clinical Research Associate Risk-Based Monitoring

**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/Clinical-Research-Associate_25111958-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_eacb57fd-7e8

## Description

Join a forward-thinking team where Risk-Based Monitoring is at the heart of how the team works. As a Clinical Research Associate (CRA), you'll collaborate with sites, data-driven insights, and focus on activities that truly impact study quality, patient safety, and success of the trial.

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.

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

- Conducts Source Document Review of appropriate site source documents and medical records.

- Verifies required clinical data entered in the case report form (CRF) is accurate and complete.

- Applies query resolution techniques remotely and on-site, and provides guidance to site staff as necessary.

- 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.

- Supports subject/patient recruitment, retention, and awareness strategies.

- Enters data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.

- 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.

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, preferably in oncology.

- Experience in risk-based monitoring is a plus.

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

- Excellent communication, presentation, and interpersonal skills.

- Fluency in German and English.

- Location in north-east Germany.

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

## Skills

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

### Nice to have
- oncology

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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/Clinical-Research-Associate_25111958-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)