Clinical Trial Associate

Cardurion Pharmaceuticals, Inc. • Burlington, MA

2d • $95,000 - $105,000 • 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 role supports clinical studies and the Clinical Operations Department through organizational tasks such as maintaining the Trial Master File, preparing agendas, minutes and tracking logs, filing, and quality reviews under the supervision of the CTM and Clinical Operations Program lead. The CTA will also participate in departmental process improvement initiatives. 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 a week.

The CTA supports day-to-day operational management of assigned clinical studies across start-up, conduct and close-out. The role includes reviewing and quality-checking study documentation, tracking deliverables and records, coordinating routine logistics with study teams and CRO/vendor counterparts, maintaining study trackers, and supporting the development, adaptation, distribution and management of study documents and systems. Some travel may be expected for internal meetings, conferences or training events.

Requirements

• 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.
• 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 tasks with guidance from the CTM or Director.
• Effective time management and organizational skills, with 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.
• Some travel may be expected for internal meetings, conferences or training events.

Nice To Haves

• MS Project and/or Smartsheet experience.

Responsibilities

• Support day-to-day operational management of assigned clinical studies, including start-up, conduct and close-out activities under the direction of the study CTM or study Director.
• Review and quality-check Trial Master File (TMF) documents; track monitoring report receipt and training records.
• Track vendor deliverables, collect metrics and file documents.
• Support multidisciplinary clinical study teams with logistics and follow-up, and communicate with CRO/vendor counterparts on routine logistics as appropriate.
• Assist with formatting, version control, quality control and distribution of study documents and plans.
• Maintain study trackers for progress against plan, including site start-up, enrollment and supplies.
• Review study document templates and site-specific adaptations, including informed consent forms (ICFs) and patient recruitment materials.
• Support logistics for developing study-related documents, including protocols, ICFs, study plans and tools, CRF Completion Guidelines, Clinical Study Reports (CSRs) and submission documentation, as appropriate, including CRO-developed plans where applicable.
• Assist with coordination of Data Monitoring Committee (DMC) and other committees 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 Clinical Operations departmental process improvement initiatives.

Benefits

• Highly competitive package with medical, dental and vision coverage.
• 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), with traditional and Roth options and a company match.
• Company-paid life insurance and short- and long-term disability insurance.
• Flexible spending accounts for medical and dependent care expenses.

What This Job Offers

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