Senior Clinical Trial Associate

About the role

We are seeking a highly motivated, goal-oriented team player to join Cardurion’s Clinical Operations team as Sr. Clinical Trial Associate (Sr. CTA).

Responsibilities

• Support Clinical Trial Managers in the day-to-day operational management of one or more clinical studies including study start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements
• Supports the multidisciplinary clinical study team and collaborates with other functions as required for implementation and execution of the study(s)
• Contributes to the development of study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), study plans and tools, patient recruitment materials, CRF Completion Guidelines, as appropriate
• Prepares study dashboards and metrics reports, as appropriate and independently supports providing key inputs to management for study oversight, operational decision making, and status updates
• Affirmatively assists in vendor oversight activities, such as tracking activities, collecting metrics and filing documents
• Analyzes trends, identifies operational risks, and recommends mitigation strategies
• Manages CRO/Clinical Service Providers (CSPs) interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, Trial Master File)
• Led and coordinated the site budget and contract negotiations
• Identifies, assesses, and proactively resolves issues before escalation when appropriate
• Mentor and onboard Clinical Trial Associates by providing training on departmental processes, systems, SOPs, study-specific procedures, and best practices; serve as an ongoing resource to support development and successful integration into the team

Requirements

• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks under limited direction
• Effective time management and organization skills with ability to multi-task and shift priorities quickly while working under tight deadlines
• Excellent interpersonal, written and verbal communication skills
• Skilled in developing collaborative internal and external relationships

Qualifications

• Requires a relevant scientific or health related field Bachelor’s degree with at least 3 years of relevant work experience in a pharmaceutical or biotechnology or CRO environment
• Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
• Experience in managing CROs and external vendors
• Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus; Experience in use of AI tools (Claude) some travel may be expected for this position including internal meetings, conferences or training events