# Senior CRA Germany

**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/Senior-CRA-Germany_25113690?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_add44ec9-6a6

## Description

Syneos Health is seeking a Senior CRA to join their team in Germany. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits.

Responsibilities:

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

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

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

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

- Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.

- Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.

- Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.

- Verify site compliance with electronic data capture requirements.

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

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

- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.

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

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

- Understand project scope, budgets, and timelines for own and others' activities in the clinical team.

- Manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met.

- Act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate.

- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.

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

- May provide training or mentorship to more junior level CRAs.

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.

- Fluency in German and English.

- Excellent communication, presentation, and interpersonal skills.

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

## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- German
- English
- Clinical Monitoring

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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/Senior-CRA-Germany_25113690?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)