Associate/Sr. Associate, Observational Research Operations

Character Biosciences • Jersey City, NJ

2d • $72,306 - $125,000 • Hybrid

About The Position

As a member of our Observational Research Operations team, you will play a key role in advancing our AMD & Glaucoma clinical programs. In this role, you’ll own operational workflows that power enrollment and longitudinal follow-up, serve as a point of contact for sites, and help strengthen the systems and processes that keep the study running smoothly at scale. You’ll work closely with cross-functional partners (Clinical, Data Science, Data, Network) to deliver a high-quality participant experience and ensure operational excellence.

This hybrid role is based in Jersey City, NJ, reporting to the Associate Director, Observational Research Operations.

Requirements

• Bachelor’s degree (or equivalent experience); advanced degree/certifications a plus
• 4–6 years of progressively responsible clinical research operations experience (biotech/pharma or CRO preferred)
• Strong clinical research domain knowledge; demonstrates ongoing professional development (training, workshops, courses)
• Deep understanding of trial processes, regulations (GCP), and clinical trial systems (CTMS, eTMF, EDC, etc.)
• Independently resolves complex/ambiguous issues, recommends process improvements, and escalates risks appropriately
• Able to juggle high-volume, technical, and sensitive work while improving team efficiency and quality
• Strong communicator and collaborator; can coordinate cross-functionally and provide peer guidance as needed
• Willing to travel up to 25% to high-profile sites based on operational needs

Responsibilities

• Serve as a primary operational leader for assigned sites, resolving issues and escalating complex challenges appropriately
• Build, monitor, and report key operational metrics (enrollment, retention, outreach performance, cycle times); surface risks and trends early, and be willing to intervene
• Identify process gaps and recommend/demonstrate improvements to increase enrollment efficiency, reduce errors, and improve patient engagement
• Provide onsite support for scheduling patient calls as needed, and assisting with patient consent and scheduling during periods of overflow and when the team needs additional support.
• Support the quality system across the observational research team - creating procedures, document control, quality control, finalization, archival, training, quality oversight etc
• Support cross-functional planning and execution for study initiatives, including site onboarding, communications, and operational readiness
• Coordinate and QC essential documentation, including regulatory and protocol/consent-related submissions in partnership with internal teams
• Travel to critical sites to support direct enrollment pushes and support our interventional trial pre-screening programs
• Analyze operational metrics across studies (outreach performance, consent/enrollment, cycle times) to identify trends and inform corrective actions
• Troubleshoot patient scheduling, consent, and engagement issues and propose solutions to address issues
• Support junior staff by sharing best practices for patient enrollment, communication, and patient talking points
• Anticipate potential operational challenges and propose mitigation strategies
• Extensive expertise in complex trial processes, technologies, and compliance requirements.
• Oversees multifaceted projects, large initiatives, or programs with significant business impact.
• Diagnoses organizational or technical challenges, designing and implementing innovative solutions.
• Handles highly technical assignments requiring strategic thinking and in-depth process refinement.

Benefits

• Benefits include a competitive salary, strong equity incentives, medical, dental, vision, 401(k), and an accrued paid time off policy.
• Character is committed to recruiting, developing, and supporting colleagues from all backgrounds. We embrace diversity, equity, and inclusion as an integral part of our culture.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level