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About the Role
Arbor Neuroscience is seeking an individual to manage human participant studies utilizing functional ultrasound imaging and focused ultrasound neuromodulation. This role involves building and managing the clinical program, including operations, IRB submissions, participant scheduling, and safety monitoring. A key aspect is developing and maintaining strong relationships with clinicians and hospital departments, and contributing to the expansion of studies into at-home settings.
Responsibilities
- Partner with scientific leadership on clinical strategy, site selection, and partnership alignment.
- Develop and own a participant recruitment program.
- Qualify and onboard clinical partners.
- Assist in designing at-home study requirements, including participant experience, logistics, and safety.
- Lead start-up for internal and external studies.
- Own IRB submissions and manage ongoing interactions.
- Manage participant scheduling, visits, follow-up, payments, and travel.
- Coordinate device deployment, equipment readiness, and study-specific technical support.
- Establish and maintain TMF, document control, clinical SOPs, and the personnel training program.
- Own adverse event tracking and reporting.
Requirements
- Substantial experience in human clinical research operations.
- Sufficient scientific training to engage substantively with clinicians and researchers.
- Written and spoken communication skills to explain research and produce key documents.
- Organizational and interpersonal skills to manage diverse stakeholders.
- Ambition to build clinical infrastructure.
- Directness and a collaborative approach.
Skills
- Clinical operations
- IRB submissions
- Protocol preparation
- Site readiness
- Participant scheduling
- Safety monitoring
- Documentation
- Training systems
- Relationship building
- Clinical strategy
- Participant recruitment
- Clinical partner onboarding
- At-home study design
- Device deployment
- Equipment readiness
- Technical troubleshooting
- TMF management
- Document control
- SOP development
- Personnel training
- Adverse event tracking
- Adverse event reporting
- Neuroscience background (nice to have)
- Neuroimaging background (nice to have)
- Neuromodulation background (nice to have)
- Hospital/academic medical center experience (nice to have)
- External clinical research partner experience (nice to have)
- Early-stage medical device/biotech experience (nice to have)
- ICH-GCP familiarity (nice to have)
- ISO 14155 familiarity (nice to have)
- FDA medical device requirements familiarity (nice to have)
- QMS experience (nice to have)
- CTMS experience (nice to have)
- eTMF systems experience (nice to have)
- AE/SAE reporting experience (nice to have)
- Monitoring experience (nice to have)
- CAPA experience (nice to have)
- Audit readiness experience (nice to have)
Location
- UK
- US
Work Type
- Full-time
- Hybrid
- Onsite
Experience Level
- Substantial experience in human clinical research operations
- Advanced training, ideally a PhD in a relevant field (preferred)
Education Level
- PhD in a relevant field (preferred)
Salary/Compensations
- $138,000 - $183,000
Benefits
- Medical, dental, and vision insurance (most plans fully covered for employee and dependents)
- 401(k) with up to 6% company match
- Company-paid life and AD&D insurance, with voluntary supplemental options
- 15 holidays plus a floating birthday holiday
- 3 weeks Paid Time Off (PTO) increasing with tenure
- Separate sick leave
About the Company
- Arbor Neuroscience is a nonprofit research organization focused on solving challenges in clinical neuroscience, specifically modulating brain circuits by design.
- The organization aims to make neuromodulation predictable and effective for conditions like depression and chronic pain.
- Arbor utilizes a new class of experiments involving intervention, circuit response measurement, symptom tracking, and repetition within individuals.
- They are developing an experimental platform including the Forest 1 ultrasound system for imaging and soon stimulation, and adding electrode-based interfaces in animal studies.
- Arbor is a Focused Research Organization within the Convergent Research family, formerly known as Forest Neurotech.
- As a mission-focused nonprofit, they conduct multidisciplinary translational work.
- They have secured initial funding and are a small, growing team where early hires will significantly shape the organization's future.
Equal Opportunity
- Arbor is an equal opportunity employer.
- Hiring is based on talent and experience.
- The company does not discriminate on the basis of race, color, religion, ethnicity, gender, gender identity, sexual orientation, disability, age, military or veteran status, or any other characteristic protected by law.