# Senior Site Activation Coordinator

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

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Bucuresti-Romania/Senior-Site-Activation-Coordinator_R1574986-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_3df34f94-a22

## Description

IQVIA is seeking a Senior Site Activation Coordinator to support clinical research studies across Romania. In this role, you will be responsible for executing site activation, regulatory, and start-up activities while working closely with investigative sites, project teams, and sponsors.

As a Site Activation Specialist, you will:

- Serve as the primary point of contact (SPOC) for investigative sites during feasibility and site activation activities.

- Coordinate site start-up and maintenance activities in compliance with local and international regulations, SOPs, and project requirements.

- Prepare, review, and manage essential site documentation, ensuring accuracy, completeness, and compliance.

- Track and follow up on regulatory, ethics, and contractual submissions and approvals.

- Submission of revised core study documents (rCSD) in CTIS (Romania) and RA & EC in Moldova.

- Site facing responsibilities (communication with PIs and site responsible persons).

- Update of ISF binders with rCSD.

- TMF upload & system tracking.

- If needed, CTA amendments for allocated studies (optional skills for this).

- Communicate document completion and activation milestones to project teams and stakeholders.

- Partner closely with Site Activation Managers, Clinical Operations teams, Project Managers, and other internal stakeholders.

We are looking for candidates with:

- Bachelor's Degree in Life Sciences, Healthcare, Pharmacy, Nursing, Biology, or a related field.

- 1 year of clinical research, site activation, regulatory affairs, clinical operations, or related healthcare experience.

- Alternatively, an equivalent combination of education, training, and relevant experience.

- Approximately 3 years of experience within a healthcare, pharmaceutical, CRO, or clinical research environment (preferred).

- Experience working with site activation, regulatory submissions, clinical trial documentation, or site management activities (preferred).

- Strong organizational skills and attention to detail.

- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.

- Excellent communication and stakeholder management skills.

Language requirements:

- Romanian: Native.

- English: Advanced (written and spoken).

In return, we offer:

- Hybrid working model.

- Opportunity to work on international clinical research projects.

- Professional development and career growth within a global organization.

- Collaborative and inclusive work environment.

- Competitive compensation and benefits package.

## Skills

### Required
- Life Sciences
- Healthcare
- Pharmacy
- Nursing
- Biology
- Clinical Research
- Regulatory Affairs
- Clinical Operations
- Romanian

### Nice to have
- Site Activation
- Regulatory Submissions
- Clinical Trial Documentation
- Site Management

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Bucuresti-Romania/Senior-Site-Activation-Coordinator_R1574986-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)