# Experienced SrCRA with oncology experience

**Company**: Syneos Health
**Location**: ROU-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/ROU-Remote/Experienced-SrCRA-with-oncology-experience---Global-Sponsor---Homebased-in-Romania_25114589?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/experienced-srcra-with-oncology-experience-00f75fd8-a68/

## Description

Syneos Health is seeking an Experienced SrCRA with oncology experience.

As a Senior Clinical Research Associate (SrCRA), you will play a critical role in ensuring the successful execution of clinical trials. You will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits.

Key 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, providing 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.

- 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.

- Manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met.

- 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 adapt to new technologies.

- Excellent communication, presentation, and interpersonal skills.

- Ability to manage required travel of up to 75% on a regular basis.

What We Offer:

- Competitive salary.

- Opportunity to work with a leading fully-integrated life sciences services organization.

- Collaborative and dynamic work environment.

- Professional development and growth opportunities.

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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/ROU-Remote/Experienced-SrCRA-with-oncology-experience---Global-Sponsor---Homebased-in-Romania_25114589?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)