# Sr CRA I

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

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHN-Remote/Sr-CRA-I---Shenyang_25113631?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_f781c9f7-ebd

## Description

Syneos Health is seeking a Senior Clinical Research Associate (Sr CRA I) to join their team in Shenyang. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

- Perform site qualification, site initiation, interim monitoring, site management, 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 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, providing guidance to site staff as necessary

- Utilize available hardware and software to support effective conduct of clinical study data review and capture

- 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

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

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

- Adapt to changing priorities to achieve goals/targets

- Act as primary liaison with project site personnel or in collaboration with Central Monitoring Associate

- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings

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

- May provide training or mentorship to more junior level CRAs

- May perform training and sign-off visits for junior CRA staff, as assigned

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

- Basic level of critical thinking skills expected

- 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
- critical thinking

---

Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHN-Remote/Sr-CRA-I---Shenyang_25113631?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)