Senior Clinical Trial Associate
Cognito Therapeutics · Cambridge, MA · hybrid
This is a rare opportunity to join a team that is bringing an entirely new category of brain health to the world. At Cognito, we are developing therapies designed to promote dignity, clarity, and coherence in the lives they touch.
Cognito is a neurotechnology company developing a new therapeutic approach to cognitive and neurological health, designed to work with the brain's own activity and biology. Born from pioneering neuroscience research at MIT, Cognito brings together neuroscience, engineering, medicine and technology to translate breakthroughs in brain science into practical therapies designed for everyday life.
Our first therapeutic application, Spectris AD, is an investigational, prescription, at-home therapy for Alzheimer's disease. With our pivotal HOPE study now complete, Cognito is entering an important new phase as we advance Spectris AD toward regulatory review, prepare for potential commercialization and continue exploring the broader potential of our science across neurological health.
We are building an interdisciplinary team united by a shared purpose: protecting and progressing the human ability to think, learn and remember. For innovators who want to work at the intersection of breakthrough science, technology and human health, Cognito offers the chance to help shape what comes next.
About the Job
We are seeking an experienced, highly organized, and proactive Senior Clinical Trial Associate to join our Clinical Operations team and play a key role in the successful execution of our clinical studies. In this role, the Senior Clinical Trial Associate will work closely with a collaborative, cross-functional team to support clinical trial planning, coordination, and oversight while independently managing assigned study activities and operational workstreams. Responsibilities include managing essential study documentation, tracking study timelines and deliverables, coordinating site and vendor activities, supporting budgets and study systems, and contributing to inspection readiness. This is a hands-on opportunity to take ownership of meaningful aspects of clinical trial operations while supporting efficient, compliant study execution.
The ideal candidate thrives in a dynamic, fast-paced environment and brings a proactive, collaborative, and solutions-oriented approach to their work. They are highly organized and detail-oriented, with strong communication, time management, and problem-solving skills, along with a solid understanding of clinical trial operations, Good Clinical Practice (GCP), and applicable regulatory requirements. They demonstrate sound judgment, take initiative, and are comfortable independently managing competing priorities while collaborating closely with the broader team. Above all, they are motivated by the opportunity to contribute to innovative therapies with the potential to make a meaningful difference in patients' lives.
Responsibilities
- Independently manage assigned clinical trial activities and operational workstreams in compliance with study protocols, SOPs, GCP, and applicable regulations.
- Oversee collection, review, filing, and reconciliation of essential study documentation, ensuring Trial Master File (TMF) completeness and inspection readiness.
- Manage preparation, maintenance, and reconciliation of Investigator Site Files (ISFs).
- Develop and maintain study trackers, timelines, and metrics to monitor enrollment, site activities, milestones, and deliverables.
- Independently manage assigned vendors and workstreams, including central laboratory activities, study supplies, and vendor deliverables.
- Manage Clinical Trial Management System (CTMS) activities, including data quality, monitoring report tracking, and resolution of outstanding action items.
- Manage assigned budget activities, including vendor invoice tracking, expense reconciliation, and CRA travel coordination.
- Oversee acquisition, renewal, and tracking of clinical assessment licenses and study materials.
- Coordinate with Data Management on EDC development, testing, data cleaning, and resolution of outstanding queries.
- Manage study system access, including user account setup, maintenance, and access tracking.
- Monitor vendor performance, KPIs, and contractual deliverables, proactively addressing issues and escalating concerns as needed.
- Coordinate Data Monitoring Committee (DMC) activities, including meeting preparation, materials, documentation, minutes, and action item follow-up.
- Independently identify and resolve operational issues, escalating significant risks to Clinical Operations leadership as appropriate.
- Collaborate with clinical sites, CROs, vendors, and cross-functional teams to ensure timely, compliant execution of study activities.
- Contribute to improvements in Clinical Operations processes, tools, and workflows to enhance quality and efficiency.
Qualifications
- Bachelor's degree (B.A./B.S.) with minimum of 5+ years of relevant work experience
- Understanding of clinical development strategies and trial designs
- Understanding of medical and statistical scientific methodology
- Working knowledge of GCP, understanding of the regulatory environment of the medical device/ pharmaceutical industry, demonstrated integrity on work-related compliance considerations and solid ethics
- Good communication skills; team player
- Ability to travel up to 15%
Competitive Benefits
Taking care of our own is one of our highest priorities. That’s why we offer benefits including unlimited PTO, wellness perks, virtual medical support, and health, dental, and vision insurance.
Physical Requirements & Work Environment
• This role is primarily performed in an office or home-office setting. Essential physical requirements include the ability to work at a computer for extended periods, communicating effectively in written and verbal formats, and participate in video and in-person meetings.
• Occasional travel to partner sites may be required. For remote roles, occasional travel to Cognito’s Cambridge, MA office may also be required.
Cognito Therapeutics is committed to providing reasonable accommodation for qualified individuals with disabilities throughout the application and hiring process. If you require accommodation, please contact us at recruitingteam@cognitotx.com.
Cognito Therapeutics is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and make employment decisions based on qualifications, merit, business needs, and job requirements. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.
All applicants must be legally authorized to work in the United States.