# Senior CRA/CRA II

**Company**: Syneos Health
**Location**: GRC-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/GRC-Remote/Senior-CRA-CRA-II---Previous-experiece-with-solid-tumor-direct-monitoring-required_25114545?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/senior-cra-cra-ii-ce83c949-cac/

## Description

Syneos Health is seeking a Senior CRA/CRA II with previous experience in solid tumor direct monitoring.

The successful candidate will work with one of Syneos Health's clients, a biopharmaceutical company, and will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits.

Key responsibilities include:

- Performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance

- Evaluating overall performance of site and site staff and providing recommendations regarding site-specific actions

- Verifying the process of obtaining informed consent has been adequately performed and documented for each subject/patient

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

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

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

- Applying query resolution techniques remotely and on site, and providing guidance to site staff as necessary

- Managing site-level activities and communication to ensure project objectives, deliverables, and timelines are met

- Providing guidance at the site and project level towards audit readiness standards and supporting preparation for audit and required follow-up actions

The ideal candidate will have:

- A 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

- Experience as CRA with a strong background in oncology clinical trials across all phases of development

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

- Phase I oncology experience

- Excellent communication, presentation, and interpersonal skills

- Multilingual capabilities, English and German

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

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.

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## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- oncology clinical trials
- solid tumor direct monitoring
- multilingual capabilities
- German

### 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/GRC-Remote/Senior-CRA-CRA-II---Previous-experiece-with-solid-tumor-direct-monitoring-required_25114545?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)