# Senior Clinical Research Associate - Biotech

**Company**: IQVIA
**Location**: Zaventem
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Zaventem-Belgium/Senior-Clinical-Research-Associate--Home-Based----IQVIA-Biotech---Belgium_R1579822?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/senior-clinical-research-associate-biotech-c6db2f15-865/

## Description

We are seeking a Senior Clinical Research Associate to perform monitoring and site management work, ensuring sites conduct studies and report data according to the study protocol, regulations, and sponsor requirements.

**Essential Functions**

- Conduct site monitoring visits, including selection, initiation, monitoring, and close-out visits, following contracted scope of work and regulatory requirements

- Collaborate with sites to adapt, drive, and track subject recruitment plans, enhancing predictability

- Provide protocol and study-related training to assigned sites, establishing regular communication lines to manage project expectations and issues

- Evaluate study site practices, ensuring proper conduct of the protocol and adherence to regulations, escalating quality issues as needed

- Manage study progress, tracking regulatory submissions, recruitment, case report form completion, and data query resolution

- Ensure site documents are available for filing in the Trial Master File and verify Investigator's Site File maintenance

- Create and maintain documentation regarding site management, monitoring visit findings, and action plans

- Collaborate with study team members for project execution support

**Qualifications**

- Bachelor's degree in a scientific discipline or healthcare preferred

- At least 1 year of on-site monitoring experience

- Equivalent combinations of education, training, and experience may be accepted

- Good knowledge of and skill in applying clinical research regulatory requirements, such as GCP and ICH guidelines

- Therapeutic and protocol knowledge, as provided in company training

- Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone and iPad where applicable

- Written and verbal communication skills, with good command of English

- Organizational and problem-solving skills, effective time and financial management skills, and ability to establish and maintain effective working relationships

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## Skills

### Required
- Good Clinical Practice (GCP)
- International Conference on Harmonization (ICH) guidelines
- Microsoft Word
- Excel
- PowerPoint
- English

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