Coordinate clinical trial site activation remotely, using regulatory documentation expertise and precise investigator site communication. Support studies from startup through conduct.
As a Site Activation Partner, you will manage essential documents and operational activities across clinical studies. You will prepare submissions, support IRB workflows, maintain committee activities, and coordinate with investigators, study teams, and stakeholders. The work includes activation, ongoing documentation, and site compliance.
Key Responsibilities:
- Coordinate startup activities and compile Investigator Initiation Packages
- Prepare and submit regulatory documents for internal approval
- Support local IRB submissions from preparation through approval
- Maintain study documents, systems, and Trial Master Files
- Resolve site issues and support audit responses
Requirements:
- Minimum two years clinical site management experience
- Knowledge of clinical trial methodologies and ICH-GCP
- Understanding of FDA and local country regulations
- Fluency in local language and English
- Life sciences education preferred
Apply clinical research knowledge, regulatory coordination, and site management skills across global clinical trial activation and conduct.
Clinical Trial Site Activation Partner in Ottawa employer: Parexel
At Parexel, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our hybrid role in Canada offers employees the flexibility to balance their professional and personal lives while providing ample opportunities for growth and development within the clinical operations field. With a strong commitment to compliance and quality, we empower our team members to make meaningful contributions to clinical trials, ensuring they feel valued and supported in their career journey.
