# CRA II

**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/CHN-Client-Hangzhou/CRA-II---Hangzhou_25112539?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_98017f69-ace

## Description

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. The Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions they shape.

**Job Responsibilities**

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

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

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

- Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, conducts Source Document Review of appropriate site source documents and medical records.

- 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 as per SOPs and Clinical Monitoring Plan/Site Management Plan.

- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

- May act as primary liaison with study 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.

**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

- 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

## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- regulatory requirements
- computer skills
- communication skills
- interpersonal 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-Hangzhou/CRA-II---Hangzhou_25112539?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)