# Clinical Research Associate (CRA)

**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/JPN-Osaka/CRA--Future-Roles-_25106960?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_b386983f-714

## Description

Syneos Health is seeking a Clinical Research Associate (CRA) to join their team in Japan.

The CRA will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits 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 and provide recommendations regarding site-specific actions

- Verify process of obtaining informed consent and document confidentiality of each subject/patient

- Assess factors affecting subject/patient's safety and clinical data integrity

- Conduct Source Document Review and verify required clinical data entered in case report form (CRF)

- Apply query resolution techniques and provide guidance to site staff

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

- Verify site compliance with electronic data capture requirements

- Perform investigational product (IP) inventory, reconciliation, and reviews storage and security

- Routinely review Investigator Site File (ISF) for accuracy, timeliness, and completeness

- Document activities via confirmation letters, follow-up letters, trip reports, and communication logs

- Support subject/patient recruitment, retention, and awareness strategies

- Enter data into tracking systems as required

- Understand project scope, budgets, and timelines, and manage site-level activities/communication

- May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate

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

- Provide guidance at site and project level towards audit readiness standards

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
- 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/JPN-Osaka/CRA--Future-Roles-_25106960?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)