About the role

You’ll lead an FDA funded study from start to finish and help build the evidence that could change how relapse risk is measured for people living with opioid use disorder.

DiMe is seeking an experienced, proactive Clinical Research Lead to take full operational ownership of Modernizing Outcome Data for Opioid Use Disorder (MOD-OUD), a multi-site clinical study funded under an FDA Broad Agency Announcement (FDABAA-26-00123). MOD-OUD is a prospective, decentralized study that aims to advance regulatory science by replacing episodic, recall-based patient reports with continuous, sensor-based relapse risk assessments.

You will lead the study across virtual-first addiction care providers and brick-and-mortar clinics, overseeing the enrollment and remote monitoring of 100 adults receiving medication for opioid use disorder (MOUD). Reporting directly to DiMe’s Principal Investigator and supported by clinical advisors, you will be the operational backbone of the study, ensuring that high-quality data is captured safely, ethically, and on schedule.

Responsibilities:

• Site startup and relationship management
  • Establish and maintain operational workflows across brick-and-mortar clinics and virtual-first addiction care platforms.
  • Train site staff on screening criteria, electronic case report forms (eCRFs), electronic informed consent, and technical onboarding.
    
    
• Digital health technology (DHT) & platform administration
  • Manage DHT inventory and logistics, including shipping wearables directly to virtual-site participants and distributing them to physical sites.
  • Configure, monitor, and troubleshoot the platforms that collect digital survey and wearable data.
  • Set up and safeguard dedicated study accounts to keep data flowing while protecting participant privacy.
  • Support sites and participants with iOS and Android compatibility issues, Bluetooth pairing failures, and app synchronization errors.
    
    
• Participant engagement, adherence, and contingency management
  • Track protocol compliance using platform dashboards.
  • Trigger automated and direct outreach when data lapses to keep participants engaged.
  • Administer and audit the study’s participant incentive schedule, tracking wearable wear time, digital survey completion, and weekly urine screening.
    
    
• Decentralized urine drug screening tracking
  • Coordinate weekly remote urine screening with US Drug Test Centers, ensuring tests are completed on time and results transfer automatically.
  • Track time-to-event endpoints and coordinate participant discharge according to protocol-defined criteria, while maintaining study blinding.
    
    
• Safety oversight, adverse event logging, and compliance
  • Monitor and record study-related adverse events, such as skin irritation from sensor wear or distress related to sensitive survey questions.
  • Escalate, document, and report serious adverse events, including overdoses and hospitalizations, to the central IRB and study leadership within 24 hours of notification.
  • Maintain central IRB approvals, amendments, and documentation in line with Good Clinical Practice (GCP), and 45 CFR Part 46.

About you

The ideal candidate brings rigorous clinical research operations experience, comfort with managing decentralized clinical trials, and an empathetic, non-stigmatizing communication style suitable for working with populations navigating substance use disorder. 

Clinical research experience

• Bachelor’s or master’s degree in clinical research, nursing, public health, health informatics, life sciences, or a related field.
• At least 2 years of clinical research experience as a CRA, CRC, or Clinical Operations Lead. Experience with decentralized clinical trials or hybrid recruitment strategies preferred.
• A track record managing multi-site studies, remote participant tracking, and central IRB operations.

Technical fluency

• Hands-on experience with electronic data capture (EDC) systems and wearable data platforms.
• Experience deploying and troubleshooting consumer wearables, mobile health apps, and sensor data pipelines.

Empathy and discretion

• A strong commitment to nonpunitive, participant-centered research.
• The ability to engage people with lived experience of substance use with empathy and professionalism, including addressing concerns about data privacy and surveillance.
• Calm judgment and de-escalation skills when handling sensitive questions, reported recurrence of substance use, or acute mental health concerns.

Ownership and collaboration

• A highly organized self-starter who can independently drive deliverables, resolve cross-site bottlenecks, and keep the study on schedule in a fully remote setting.
• A clear communicator who works smoothly across clinicians, data scientists, vendors, and participants.

What we offer

• The opportunity to shape the future of digital medicine at a global scale.
• A collaborative, high‑trust, high‑performance team environment.
• Meaningful work with leading organizations across healthcare, life sciences, and technology.
• Flexible, fully remote work.
• Competitive compensation and benefits.