# Clinical Research Associate (Start-Up) - Oncology

**Company**: ICON Strategic Solutions
**Location**: Blue Bell
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/US-Blue-Bell-ICON/Clinical-Research-Associate---SOAR_JR160431-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_f969a2ed-1f6

## Description

As a Clinical Research Associate (Start-Up) - Oncology at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

You will be responsible for multiple trials within cross therapeutic areas, with a focus on start-up.

Key responsibilities include:

- Collaborating with country operations teams to identify, select, and activate clinical trial sites

- Performing Site Qualification Visits (SQVs) to assess site eligibility

- Building strong relationships with site personnel

- Ensuring adherence to ICH-GCP guidelines, local regulatory standards, and internal SOPs

- Coordinating with country operations teams to collect essential documents

- Acting as the main point of contact for sites, study teams, and external stakeholders

- Managing investigator contracts, regulatory documents, and site-specific start-up activities

- Providing regular status updates to internal and external stakeholders

- Monitoring, reporting on, and analyzing KPIs related to site selection and start-up timelines

- Proactively identifying and addressing issues that may delay study initiation or affect trial deliverables

- Maintaining precise documentation for inspections

- Supporting sites during the activation phase

- Facilitating coordination with site staff to ensure pre-study requirements are met

- Possibly assisting in audit and inspection preparations

Requirements include:

- Minimum B.S., R.N., or equivalent degree, preferably in Biological Sciences

- 2-3 years' experience in monitoring pharmaceutical industry clinical trials

- 1-3 years' experience monitoring oncology clinical trials

- Study start-up experience required

- Analytical/risk-based monitoring experience is an asset

- Ability to drive patient recruitment strategies

- Ability to partner closely with investigator and site staff

- Strong communication and influencing skills

- In-depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements

- Legal authorization to work in the United States

ICON offers a competitive and comprehensive total rewards package, including:

- Competitive base salary and performance-related incentives

- Health and wellbeing programmes

- Retirement and pension plans

- Life assurance and disability coverage

- Employee assistance programmes and wellbeing resources

- Learning and development opportunities

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## Skills

### Required
- Good Clinical Practice
- ICH guidelines
- CTMS
- EDC
- eTMF
- IWRS
- safety reporting

### Nice to have
- analytical/risk-based monitoring
- oncology clinical trials

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/US-Blue-Bell-ICON/Clinical-Research-Associate---SOAR_JR160431-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)