Site Start-Up Specialist
World Health Research (WHR) is seeking a dedicated Site Start-Up Specialist to support our study team—including the project manager, project coordinator, and administrative assistant. This role is focused on overseeing and coordinating the initial phases of clinical trial operations, including site identification, feasibility assessments, regulatory submissions, and study initiation activities.
The ideal candidate is detail-oriented, collaborative, and highly organized, with a strong understanding of clinical research practices and regulatory frameworks.
Key Responsibilities
- Collaborate with internal and external stakeholders to manage site identification, invitation, selection, and feasibility processes.
- Prepare, review, and submit regulatory documents in compliance with local, regional, and international guidelines.
- Coordinate with clinical sites to facilitate contracts, budgets, and essential document collection.
- Monitor and communicate progress of study start-up activities, addressing any issues or delays.
- Ensure adherence to timelines, budgets, and regulatory requirements.
- Maintain and update databases, trackers, and documentation.
- Develop newsletters and update the study websites regularly.
- Serve as the primary point of contact for internal and external stakeholders regarding start-up activities.
Qualifications and Experience
- Bachelor’s degree in health sciences or a related field.
- Minimum 2 years of recent experience in clinical trials or large research studies, especially in study start-up.
- Strong knowledge of ICH-GCP, Health Canada Division 5, and clinical trial regulations.
- Excellent communication, negotiation, and problem-solving skills.
- Proficiency in Microsoft Office Suite.
- Ability to work independently and within cross-functional teams with strong initiative and self-direction.
About World Health Research
www.worldhealthresearch.ca
Our members improve health through research, education, and advocacy. A beacon of scientific rigour, WHR is dedicated to supporting and championing transformative discoveries that reshape the medical landscape.
To Apply
Please send your resume and cover letter to: human-resources@worldhealthresearch.ca