# FSO Experienced 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-Tokyo-Hybrid/FSO-CRA-II---Sr-CRA_25107273?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_d648ecaf-31f

## Description

Syneos Health is seeking an experienced Clinical Research Associate (CRA) to join their team. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits. The CRA will ensure regulatory, ICH-GCP, and protocol compliance, and provide recommendations regarding site-specific actions.

Responsibilities:

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

- Ensure regulatory, ICH-GCP, and protocol compliance

- Evaluate overall performance of site and site staff and provide recommendations

- Verify process of obtaining informed consent and document confidentiality of subjects/patients

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

- Conduct Source Document Review and verify clinical data entered in case report forms

- 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 inventory, reconciliation, and reviews storage and security

- Routinely review Investigator Site File and reconcile contents with Trial Master File

- 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 to track observations and action items

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

- Act as primary liaison with study site personnel and Central Monitoring Associate

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

- Provide guidance on audit readiness standards and support preparation for audits

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 compliance
- clinical research
- site management

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/JPN-Tokyo-Hybrid/FSO-CRA-II---Sr-CRA_25107273?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)