Position Title: Sr. Clinical Research Associate / Clinical Trial Manager
Location: Cambridge, MA

Company Description

Cognito is a venture backed (Morningside Ventures) startup company translating scientific findings from MIT into therapeutic approaches for Alzheimer’s disease and other neurodegenerative conditions. We are a fast moving, highly motivated team of people with the ambitious goal of helping the millions of Alzheimer’s disease patients and caregivers around the world. With our patented
gamma stimulation technology, we are committed to developing non-invasive device-based therapies. Developing this unique platform requires expertise across a range of fields. Engineering, Software Engineering, Regulatory, Clinical, Product Design, Data Science, QA, Business Development, Marketing, just to name a few. We are looking to grow our world-class team of scientists and medical device innovators who want to make a difference and improve people’s lives on an everyday basis.

Summary of Role

We are seeking a Clinical Research Associate or Clinical Trial Manager (commensurate with experience) to join our company who can roll-up their sleeves and help us manage the collection and analysis of clinical data. You will coordinate and oversee all CRO/clinical site/vendor activities, including being the primary contact between trial sites and Cognito. You will work side-by-side with the Associate Director of Clinical Affairs to assist in clinical trial management tasks as delegated (e.g. trip report review, issue tracking, protocol deviation review, and field support team management), with a focus on providing support during clinical study planning, the development and production of timelines, budgets, and various study plans throughout the duration of each clinical trials.

Deliverables

You will be responsible for:

• Planning and implementing activities required to conduct and monitor clinical trials in accordance with protocols and applicable Standard Operating Procedures (SOP), Good Clinical Practices (GCP), ICHs and applicable local regulations
• Performing all activities of site selection and establishing relationships with trial sites, monitoring/co-monitoring, managing, and closing clinical study sites
• Liaising with CROs and other clinical vendors as directed to ensure deliverables are met and methods of communication are developed to facilitate efficient work flow
• Assisting in the management of study progress (from protocol development and planning to study close-out) to assure adherence to intended timelines and achievement of key milestones and overall study goals

Who You Are

You’re someone who likes the pace and energy of a startup company and wants to influence your own development. You’re looking for an early stage company with an exciting technology, where you have the opportunity to make a difference for patients around the world. You will have an entrepreneurial and team spirit, a strong motivation to learn, and the ability to develop creative solutions to complex problems. You are able to work independently as well as part of a close team, demonstrating strong interpersonal, speaking, and writing abilities. Along with being highly organized and detail-oriented, you will have excellent time management and project management skills.

Minimal Qualifications

• B.A./B.S. with 3+ years of relevant work experience
• Comprehensive understanding of clinical development strategies and trial designs
• Understanding of medical and statistical scientific methodology
• In-depth understanding of the legal and regulatory environment of the medical device/ pharmaceutical industry, demonstrated integrity on work-related compliance considerations and solid ethics
• Good communication skills; team player

Contact

Interested? Send a short introduction and resume to jobs@cognitotx.com

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