# CRA II

**Company**: Syneos Health
**Location**: ESP-Remote (Madrid)
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/ESP-Remote-Madrid/CRA-II-Galicia-Sponsor-dedicated_25114540?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/cra-ii-6393a324-177/

## Description

Syneos Health is seeking a CRA II to join their Clinical Solutions team. The successful candidate will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits. They will also verify the process of obtaining informed consent, assess factors that might affect subject/patient's safety and clinical data integrity, and apply query resolution techniques.

Responsibilities:

- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits

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

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

- 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

- May 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

Qualifications:

- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience

- 3-4 years of experience as CRA

- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

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

- Experience in Immunology, Cardiology, Pulmonary Hypertension, Ophthalmology, or Lipids

- Excellent communication, presentation, and interpersonal skills

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## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- clinical monitoring
- site management
- regulatory compliance

### Nice to have
- Immunology
- Cardiology
- Pulmonary Hypertension
- Ophthalmology
- Lipids

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/ESP-Remote-Madrid/CRA-II-Galicia-Sponsor-dedicated_25114540?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)