# Sr CRA with SSU activities in Oncology - Sponsor dedicated - Home Based Hungary

**Company**: Syneos Health
**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/HUN-Budapest/Sr-CRA-in-Oncology---Sponsor-dedicated---Home-Based-Hungary_25113219?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_abb267dd-aeb

## Description

We are seeking a Senior Clinical Research Associate (CRA) to join our team in Hungary. As a Sr CRA, you will be responsible for performing regulatory activities, site qualification, site initiation, interim monitoring, site management, and close-out visits.

Responsibilities:

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

- Evaluate overall performance of site and site staff, and provide recommendations regarding site-specific actions

- Verify the 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 appropriate 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, and provide guidance to site staff as necessary

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

- May 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

- May 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

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 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 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/HUN-Budapest/Sr-CRA-in-Oncology---Sponsor-dedicated---Home-Based-Hungary_25113219?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)