# CRA II or Sr CRA (sponsor dedicated)

**Company**: Syneos Health
**Location**: CHL-Remote
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHL-Remote/CRA-II-or-Sr-CRA--sponsor-dedicated----Min-3-years-of-prev-exp-in-monitoring---Santiago--home-based_25109766?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/cra-ii-or-sr-cra-sponsor-dedicated-bb8199a1-684/

## Description

Syneos Health is seeking a CRA II or Sr CRA (sponsor dedicated) to work from home in Santiago.

The successful candidate will have a minimum of 3 years of previous experience in monitoring.

**Job Responsibilities**

- Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

- Evaluates the overall performance of site and site staff, providing recommendations regarding site-specific actions.

- Communicates and escalates serious issues to the project team and develops action plans.

- Maintains a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

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

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

- Conducts Source Document Review of site source documents and medical records.

- Verifies required clinical data entered in the case report form (CRF) is accurate and complete.

- Applies query resolution techniques remotely and on-site, and provides guidance to site staff as necessary.

- 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.

- Supports subject/patient recruitment, retention, and awareness strategies.

- Enters data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.

- 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.

- 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.

**Benefits**

Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

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## 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/CHL-Remote/CRA-II-or-Sr-CRA--sponsor-dedicated----Min-3-years-of-prev-exp-in-monitoring---Santiago--home-based_25109766?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)