Position Title: Field Support Clinical Research Associate
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 Field Support Clinical Research Associate to join our team who can work in the office, at clinical sites and in subject homes to support successful use of our experimental devices. You will provide technical support with the device as well as work with the clinical site and subjects to support protocol adherence strategies. Excellent communication skills will be essential in
ensuring all parties are informed and your creativity will support innovative problem solving. Comfort with cutting edge technology, troubleshooting skills and a willingness to learn will aid in your success. You will also work closely with the Associate Director of Clinical Affairs to support clinical trial management tasks as delegated (e.g. trip report review, issue tracking, and protocol deviation review), 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.

Our culture is very open and innovative, and due to the multidisciplinary nature of building a complex device, you will be collaborating with teams from a variety of fields, including neuroscientists, engineers, and medical device professionals.

Deliverables

You will be responsible for:

• Scheduling site and subject home visits according to protocol requirements and attending those visits, some of which may be out of traditional business hours
• Planning and adapting the field support model to suit evolving needs within clinical trials and subject populations
• Learning and troubleshooting the technical specifications for devices in use in a variety of settings
• Ensuring communication is adequate between Cognito, clinical sites and subjects with respect to field support visits and supporting data collection and protocol adherence
• 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
• 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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