Senior Clinical Trial Associate

Cardurion Pharmaceuticals, Inc. • Burlington, MA

2d • $90,000 - $100,000 • Hybrid

About The Position

Cardurion Pharma is a clinical-stage biotechnology company focused on discovering and developing novel therapeutic approaches for cardiovascular disease. They are seeking a highly motivated, goal-oriented team player to join their Clinical Operations team as a Sr. Clinical Trial Associate (Sr. CTA). This role supports the operational planning and execution of Global Phase 1-3 clinical studies, working closely with Clinical Trial Managers. The Sr. CTA will coordinate study documents, vendor activities, maintain study tracking, perform filing and quality reviews, and support site start-up and monitoring activities. This position requires a proactive individual who can manage competing priorities in a lean environment and drive operational excellence. The role requires being onsite in the Burlington office three days a week.

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
• Must have excellent interpersonal, written and verbal communication skills
• Skilled in developing collaborative internal and external relationships
• Ability to effectively communicate, collaborate, and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
• 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)

Nice To Haves

• MS Project and/or Smartsheet a plus
• Experience in use of AI tools (Claude)

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.
• Assist 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)
• Leads and conducts routine reviews of key trial operational deliverables including, but not limited to monitoring report review, TMF status and completeness checks, organizing internal TMF QC processes and reconciliation activities, maintenance of study team training records.
• Participates in the development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materials
• Organizes internal team meetings, supports planning of investigator meetings and other study-specific meetings as appropriate
• Track study milestones, deliverables, and action items to support study timelines.
• Review of site activation document packages
• Leads and coordinates 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.

Benefits

• Highly competitive package with healthcare coverage including medical, dental and vision
• Fully funded Healthcare Savings Account for high-deductible PPO Plan
• 4 weeks paid time off annually
• 10 company paid holidays and year-end shut down
• 401k (traditional and Roth offered) with company match
• A suite of Cardurion paid insurance coverage, including life insurance, short-term and long-term disability
• Flexible spending accounts for medical and dependent care expenses

What This Job Offers

• Job Type: Full-time
• Career Level: Senior