# CRA II

**Company**: Syneos Health
**Location**: CHN-Client
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHN-Client/CRA-II--Shanghai_25114155?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_357ba14d-814

## Description

Syneos Health is seeking a Clinical Research Associate II (CRA II) to join their team in Shanghai. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits. The CRA II will work closely with the project team to ensure regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

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

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

- Verify 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

- 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

- 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

- 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

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

- Good computer skills and ability to adapt to new technologies

- 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
- regulatory requirements
- computer skills
- communication skills

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHN-Client/CRA-II--Shanghai_25114155?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)