# Senior Clinical Research Associate

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

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Dublin-Ireland/SR-CRA-I_R1574476?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_0015b02b-ac8

## Description

Join IQVIA on our mission to accelerate innovation for a healthier world!

IQVIA's Site Management team is seeking a Senior Clinical Research Associate in Ireland to cover UK & Ireland sites.

**Responsibilities**

- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability

- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues

- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate

- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase

- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements

- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation

- Collaborate and liaise with study team members for project execution support as appropriate

**Requirements**

- Requires at least 3-5 years of on-site monitoring experience in interventional clinical trials, including Oncology TA

- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

- Ability to establish and maintain effective working relationships with coworkers and clients

- Full driving license and vehicle required for travel

**Benefits**

- Genuine career development opportunities to grow as we grow

- Flexible working to assist work–life balance and professional success

- Well-being support covering your physical, mental, and financial health

## Skills

### Required
- Good Clinical Practice (GCP)
- International Conference on Harmonization (ICH) guidelines
- clinical research regulatory requirements
- Oncology TA

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