# Sr CRA I / Sr CRA II - Sponsor dedicated

**Company**: Syneos Health
**Location**: Madrid, ESP-Remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/ESP-Remote-Madrid/Sr-CRA-I---Sr-CRA--II---Sponsor-dedicated-Spain--Madrid-_25114125?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_b8624452-ca4

## Description

Syneos Health is seeking a Sr CRA I / Sr CRA II - Sponsor dedicated to join their Clinical Solutions team. The successful candidate will perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

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

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

- Verify 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

- Conduct Source Document Review of site source documents and medical records

- Apply query resolution techniques remotely and on-site

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

- Verify site compliance with electronic data capture requirements

- Perform investigational product (IP) inventory, reconciliation, and reviews storage and security

- Routinely review 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

- 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

- Adapt to changing priorities to achieve goals/targets

- 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 site and project level towards audit readiness standards

- 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

- Minimum of 5+ years of experience in the pharmaceutical/biotechnology industry monitoring as a Clinical Research Associate

- 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
- clinical research
- regulatory compliance
- 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/ESP-Remote-Madrid/Sr-CRA-I---Sr-CRA--II---Sponsor-dedicated-Spain--Madrid-_25114125?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)