# Clinical Research Site Monitor

**Company**: IQVIA
**Location**: Montreal
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Mississauga-Ontario-Canada/Associ-e--de-recherche-clinique--ARC--principal-e----Senior-Clinical-Research-Associate--Sponsor-Dedicated_R1574224?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_53deed7b-b11

## Description

We are seeking a Clinical Research Site Monitor to perform monitoring and site management work for a variety of protocols, site and therapeutic areas. As a Site Monitor, you will be responsible for ensuring that clinical trials are conducted in accordance with Good Clinical Practice (GCP) and regulatory requirements.

**Responsibilities**

- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements

- Work with sites to adapt, drive and track subject recruitment plans 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

- 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

- 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 / ICH 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

- Act as a mentor for clinical staff including conducting co-monitoring and training visits

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

**Requirements**

- Bachelor's Degree in a scientific discipline or health care preferred

- At least 3 years of on-site monitoring experience

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

- Strong therapeutic and protocol knowledge as provided in company training

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

- Written and verbal communication skills including good command of English language

- Effective time and financial management skills

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

## Skills

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

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Mississauga-Ontario-Canada/Associ-e--de-recherche-clinique--ARC--principal-e----Senior-Clinical-Research-Associate--Sponsor-Dedicated_R1574224?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)