Senior Clinical Research Professional

Our team is seeking a skilled and experienced Senior Clinical Research Associate to join our dynamic team. As a key member of our team, you will play a crucial role in accelerating drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity.

You will be joining a program that takes an extensive co-monitoring approach, enabling a supportive and collaborative work environment. Frequent, consistent communication, both internally and with our client, positions our program to be closely aligned on our shared goals.

• Complete onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel, and study close out.
• Verify the protection of study participants by confirming informed consent procedures and protocol adherence according to applicable regulations.
• Ensure the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and SOPs.
• Manage investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data submission.
• Verify proper management and accountability of Investigational Product (IP).
• Write and submit reports of investigational site findings and update applicable tracking systems. Escalate observed deficiencies, issues, and corrective and preventative action plans as appropriate.
• Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assist with resolution of investigational site/data queries.
• Perform key risk assessment and management responsibilities throughout the project, including site health analysis, process evaluation, and project escalation.
• Participate in audit preparation and follow-up activities as needed.
• Independently perform various onsite and offsite monitoring visit types.
• Gather and review information for assigned sites and identify inconsistencies. Assess risk and escalate as appropriate with limited guidance.
• Assist with non-complex adhoc, short-term assignments supporting additional studies or initiatives.
• May serve as preceptor, providing training to less experienced team members.Requirements:
  • Holding an undergraduate degree or international equivalent in clinical, science, or health-related fields from an accredited institution; health care professional licensure (e.g., registered nurse).
  • Having previous experience supporting clinical trials, including solid on-site monitoring experience.
  • Willing to travel 50-80%.
  • Equivalent education, training, and relevant experience may be considered; fluent in English and host country language.
  What We Offer:
  • Annual leave entitlements
  • Health insurance options
  • Retirement planning options
  • Global Employee Assistance Programme with TELUS Health
  • Life assurance
  • Flexible country-specific benefits (childcare vouchers, bike schemes, gym discounts, travel passes, health assessments, etc.)

We are committed to providing an inclusive, accessible environment and a workplace free of discrimination and harassment. Qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you require reasonable accommodations during the application process or to perform job functions, please inform us.

Join us if you have the skills and experience we need to make a difference in this critical role.