# Single Sponsor CRA II/Sr CRA with Oncology experience

**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/Single-Sponsor-CRA-II-Sr-CRA-with-Oncology-experience_25114109?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_9293387b-f9d

## Description

Syneos Health is seeking a well-qualified CRA II or a Senior CRA with a strong background in oncology clinical trials across all phases of development.

**Job Responsibilities**

- Performs site qualification, site initiation, interim monitoring, site management and close-out visits to ensure regulatory, ICH-GCP 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 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.

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

- May act as primary liaison with project 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.

- 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.

- A well-qualified CRA II or a Senior CRA with a strong background in oncology clinical trials.

- Experience with early phase/first-in-human studies, safety, PK/PD, and dose-escalation designs.

- Hands-on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer.

- Fluency in both English and German.

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

- Excellent communication, presentation and interpersonal skills.

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

**Benefits**

Syneos Health offers a comprehensive benefits package, 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
- Oncology clinical trials
- German
- English
- Computer skills

### Nice to have
- Toll-Like Receptor (TLR) pathways
- PARP1 inhibitors
- Werner helicase protein

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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/Single-Sponsor-CRA-II-Sr-CRA-with-Oncology-experience_25114109?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)