Site Activation Specialist II

This is a fully remote position, open to applicants in Canada.

📋 Description

• Accountable for delivering quality results at the country level while ensuring adherence to project specifications and relevant national regulations.

• Monitor submission and approval timelines within the SSU tracking system and address or escalate any delays encountered.

• Oversee basic financial aspects of the project and contracted hours/tasks, raising any discrepancies as necessary.

• Review and adhere to Standard Operating Procedures (SOPs) and Work Instructions, while maintaining training records and ensuring compliance with timesheets.

• Foster continuous improvement in Site Start-Up processes, including submissions, essential document collection, and communication with authorities and ethics committees.

• Submit pertinent documents to the Trial Master File.

• Prepare and submit applications for central and local ethics committees, regulatory authorities, and hospital approvals.

• Prepare ongoing submissions, amendments, periodic notifications, and safety notifications as mandated by local regulations.

• Act as a liaison between investigational sites and functional leads, overseeing the complete site activation process.

• Serve as a country-level subject matter expert on site start-up and clinical trial regulatory requirements.

• Maintain local regulatory knowledge in the central repository and assist with data protection guidance.

• Contribute to local SOPs, work instructions, and internal training materials.

• Assist in resolving issues with ethics committees or competent authorities.

• Support activities related to site selection and feasibility.

• Aid in the negotiation of investigator contracts and budgets, including contract preparation, quality control, execution, archival, and metadata collection.

⛳️ Requirements

• Bachelor’s Degree.

• Comprehensive understanding of the clinical trial process across Phases II-IV and ICH GCP.

• Ability to comprehend clinical protocols and associated study specifications.

• In-depth knowledge of clinical trial start-up processes.

• Capability to effectively manage external vendors for contract negotiations.

• Strong organizational skills with the ability to adeptly handle multiple tasks.

• Excellent written and verbal communication skills, along with strong interpersonal abilities.

• Proficiency in managing multiple project budgets that entail increased complexity and value.

• Quality-focused in all tasks undertaken.

• Effective negotiation skills.

• Strong problem-solving capabilities.

• Proven ability to work independently as well as collaboratively within a team.

• Equivalent experience, skills, and/or education may also be taken into consideration.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations when necessary.