# Sponsor Dedicated CRA I/II

**Company**: Syneos Health
**Location**: Sofia
**Work arrangement**: hybrid
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/BGR-Remote/Sponsor-Dedicated-CRA-I-II---Sofia-Area_25111507?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_fd2f2e4e-377

## Description

Syneos Health is seeking a Sponsor Dedicated CRA I/II to join their team in the Sofia area. As a CRA, you 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, providing recommendations regarding site-specific actions

- Verify process of obtaining informed consent, protect confidentiality of subjects/patients

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

- Conduct Source Document Review, verify clinical data entry, apply query resolution techniques

- Manage investigational product inventory, reconciliation, and storage/security

- Review Investigator Site File, reconcile contents with Trial Master File

- Document activities via confirmation letters, follow-up letters, trip reports, and other required project documents

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

- Enter data into tracking systems to track observations, ongoing status, and assigned action items

- Adapt to changing priorities to achieve goals/targets

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

- Prepare for and attend Investigator Meetings and/or 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

- Previous exposure (up to 2 yrs) to monitoring activities

- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

- Good computer skills, ability 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/BGR-Remote/Sponsor-Dedicated-CRA-I-II---Sofia-Area_25111507?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)