Clinical Trial Associate

Cardurion Pharmaceuticals • Burlington, MA

5d • Hybrid

About The Position

Cardurion Pharma is seeking a highly motivated, goal-oriented team player to join its Clinical Operations team as a Clinical Trial Associate (CTA). The CTA supports clinical studies and the Clinical Operations Department with organizational tasks, including Trial Master File maintenance, preparation of agendas and minutes, tracking logs, filing, and quality reviews under the supervision of the CTM and Clinical Operations Program Lead. The position also participates in departmental process-improvement initiatives.

The role supports day-to-day operational management of assigned clinical studies from start-up through conduct and close-out. The CTA works with study teams and CRO or vendor counterparts on routine logistics, maintains study documentation and trackers, and assists with study meetings, committee coordination, and document development. The position reports to the relevant study-specific Director or Program Lead of Clinical Operations and is required to be onsite in the Burlington office three days per week. Some travel may be expected for internal meetings, conferences, or training events.

Requirements

• Proven experience handling confidential and sensitive information with discretion and good judgment; honesty, integrity, and trust-building behaviors are essential.
• Self-motivated, with initiative and the ability to take ownership of and follow through on specific tasks with guidance from the CTM or Director.
• Strong time-management and organizational skills, including the ability to multitask and shift priorities quickly under tight deadlines.
• Excellent interpersonal, written, and verbal communication skills.
• Ability to develop collaborative internal and external relationships.
• Ability to communicate and collaborate effectively and deliver excellent work in a fast-paced, rapidly growing, dynamic company.
• Bachelor’s degree in a scientific or health-related field, or equivalent experience.
• At least 1 year of clinical operations or trial support experience at a Sponsor, or at least 2 years at a CRO.
• Working knowledge of ICH-GCP and familiarity with eTMF and CTMS systems.
• Exposure to CRO and vendor coordination in an outsourced Clinical Trial structure.
• Demonstrated proficiency in MS Office, including Outlook, Word, Excel, and PowerPoint.

Nice To Haves

• Proficiency with MS Project and/or Smartsheet.

Responsibilities

• Support day-to-day operational management of assigned clinical studies, including study start-up, conduct, and close-out activities under the direction of the study CTM or study Director.
• Review and quality-check Trial Master File documents and track monitoring report receipt and training records.
• Track vendor deliverables, collect metrics, and file documents.
• Support the multidisciplinary clinical study team with logistics and follow-up, and communicate with CRO and vendor counterparts about routine logistics as appropriate.
• Assist with formatting, version control, quality control, and distribution of study documents and plans.
• Maintain study trackers to support tracking of study progress against plans, including site start-up, enrollment, and supplies.
• Review study document templates and site-specific adaptations, including informed consent forms and patient recruitment materials.
• Support logistics for developing study-related documents, including protocols, informed consents, study plans and tools, CRF Completion Guidelines, Clinical Study Reports, and submission documentation, as appropriate.
• Assist in coordinating Data Monitoring Committee and other committee activities as needed.
• Schedule internal team meetings; prepare agendas, minutes, and action-item logs; and support investigator meeting and other study-specific meeting logistics as appropriate.
• Provide input on SOPs and templates as appropriate.
• Manage study system access and user requests.
• Participate in process-improvement initiatives across the department.

Benefits

• Healthcare coverage including medical, dental, and vision.
• Fully funded Healthcare Savings Account for the high-deductible PPO plan.
• Four weeks of paid time off annually.
• Ten company-paid holidays and a year-end shutdown.
• 401(k) plan with traditional and Roth options and company match.
• Company-paid insurance coverage, including life insurance and short- and long-term disability.
• Flexible spending accounts for medical and dependent care expenses.

What This Job Offers

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