In-House CRA

Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX) company translating scientific findings from MIT into therapeutic approaches for Alzheimer's disease and other neurodegenerative conditions. We received FDA Breakthrough Device Designation based on our Phase 2 data that showed preservation of both brain function and structure in Alzheimer's patients. Our device is in a pivotal study for first-line treatment of Alzheimer's, with potential expansion into Mild Cognitive Impairment (MCI) and Parkinson's Disease. We are a fast-moving, highly motivated team with a bold mission of bringing a novel therapy to the millions of patients in the world suffering from neurodegenerative diseases. With our patented gamma stimulation technology, we are committed to developing a pipeline of non-invasive device-based therapies.

The Role

The Clinical In-house CRA participates in research and development activities within the Clinical Operations team at Cognito. This role is responsible for supporting the planning, implementation, and tracking of the clinical monitoring process, administration of clinical research, the science of determining the safety and effectiveness (prevention, treatment, diagnosis and/or symptom relief) of investigational interventions for human use. In addition, the role is responsible for tracking and management of complex clinical trial data and systems.

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 clinical sites, contract research teams, neuroscientists, engineers, and medical device professionals. Successful teammates are committed to the collaboration and new technology and enjoy a small, flexible and innovative team.

Roles and Responsibilities

You will be responsible for:

• Supporting site management activities with clinical trial sites and serving as a main point of contact for site questions and requests
• Establishment of strong relationship with clinical sites by frequent communication, teleconferences and (as needed), site visits
• Identifying and developing site by site mitigation plans for barriers to enrollment
• Collaborating with Data Management and CRO to identify and correct missing documentation, queries, results
• Coordinating collection of essential regulatory and study documentation from clinical trial sites
• Maintaining site recruitment plans and ongoing dialogue regarding recruitment efforts
• Collaboration with marketing team on directing advertising, local engagement opportunities and guiding marketing campaign to support site needs
• Remote review of source documentation and/or remote QC of data
• Participate in site co-monitoring activities and oversight of CRO
• Review of study visit reports
• Managing shipments of marketing and recruitment materials to sites
• Collaborating with colleagues at all levels and in all departments of the company to ensure company success, including coordinating activities and timelines between members of the Clinical Operations team
• Under supervision of the Clinical Trial Manager, file and maintain routine documentation within the Trial Master File (TMF)
• Tracking and Monitoring of subject visits, enrollment, enrollment forms
• Review of clinical study documentation and ensure vendor compliance with study plans (i.e. clinical monitoring plan)
• In conjunction with the clinical trial manager, assist with oversight of specific clinical trial vendor
• Maintain Internal team training records, ensure documentation records accurately reflect SOP requirements
• Participation In clinical trial team meetings, preparing agendas and distributing minutes where required

Qualifications

• Bachelors Level degree or higher
• 2-3 years of relevant clinical research experience as CRA, CTA, study coordinator or similar
• Understanding of Good Clinical Practices (GCP), ICHs and applicable local regulations
• Understanding of medical and statistical scientific methodology
• Strong problem solving abilities, able to adapt to changing environments and requirements
• Strong attention to detail
• Ability to identify team needs and take initiative to support team functionality
• Excellent interpersonal and communication skills; team oriented
• Proficiency with MS Office

DesiredQualifications

• Experience with populations with neurodegenerative diseases
• Human subjects research background
• Understanding of Good Clinical Practices (GCP), ICHs and applicable local regulations