Site Activation Specialist

Power up clinical trials from the ground up-be the spark behind seamless site activation!

Proclinical is seeking a Site Activation Specialist to support site start-up activities for assigned studies within the Clinical Operations team. This role involves collaboration with multiple stakeholders, including study teams, CROs, and investigational sites, to ensure timely and high-quality site activation deliverables. The position offers a hybrid work model, requiring on-site presence 2-3 days per week in Rotkreuz, Switzerland.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities :

• Oversee and manage site activation deliverables across all regions for assigned projects.
• Support pre-study site identification and selection by collecting and analyzing site feasibility information.
• Maintain regular communication with investigational sites and CROs to ensure timely completion of site activation activities and resolve issues as needed.
• Collect, review, and manage study-specific regulatory and essential documents in line with SOPs, guidelines, and timelines.
• Coordinate submissions to IRBs, Ethics Committees, and other regulatory authorities in collaboration with sites and study teams.
• Ensure informed consent forms meet regulatory and company requirements.
• Facilitate translation of essential documents for regulatory submissions as required.
• Manage clinical trial insurance processes and support throughout the study.
• Assist with contract and budget negotiations alongside contracting and study teams.
• Ensure timely completion of purchase orders and Fair Market Value assessments.
• Support study instrument placements and import / export licensure processes.
• Implement and support the use of eTools at investigational sites.
• Maintain and update regulatory intelligence at country, state, and site levels.
• Collaborate with study teams to ensure timely completion of start-up tasks.
• Address and escalate issues to study teams as necessary.
• Support internal audits, external inspections, and contribute to corrective and preventive actions (CAPAs).

Key Skills and Requirement s :