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.