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). Reporting to the Senior Manager, Clinical Operations Oversight & Excellence, the Sr. CTA supports the operational planning and execution of one or more Global Phase 1-3 clinical studies. Working closely with the Clinical Trial Managers, the Sr. CTA coordinates study documents, vendor activities, maintaining study tracking, filing and quality reviews as well as supporting site start-up and monitoring activities. The Sr. CTA will play a key role in working with cross-functional Cardurion team members, as well as team members from vendors and CROs in completing all required tasks to meet departmental and project goals. This role is required to be onsite in Burlington office 3 days a week.
In a lean environment, this role requires a highly organized, proactive individual who can effectively manage competing priorities, demonstrate a roll-roll-up-your-sleeves mentality, and drive operational excellence across Clinical Operations.
Here's What You'll Do: - 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.
Here's What We'll Bring to the Table:- 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
Expected Pay Range: $90,000-$100,000
Requirements
Here's What You'll Bring to the Table: Core Competencies- 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.
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
