Clinical Coordinator

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Assist in the daily management of observational, interventional, and real-world evidence studies.

• Support study initiation tasks, including site onboarding, documentation, and tracking timelines.

• Oversee study schedules, task plans, and facilitate internal communication among stakeholders.

• Coordinate logistics for samples, participant workflows, and data collection activities.

• Aid in IRB submissions, amendments, and ongoing reviews in collaboration with study leadership.

• Ensure precise maintenance of study documentation, such as protocol files, consent forms, and essential trial documents.

• Guarantee that study activities comply with HIPAA regulations and relevant clinical research standards.

• Collaborate with Science, Bioinformatics, and Product teams to enhance metadata capture and study execution.

• Act as a liaison for external collaborators, research sites, and CRO partners.

• Convert study requirements into clear operational procedures and ensure follow-through.

• Assist in clinical study reporting, including progress updates, interim summaries, and final documentation.

• Help prepare materials for abstracts, manuscripts, partner updates, and internal presentations.

• Monitor study metrics and proactively identify operational risks or bottlenecks.

⛳️ Requirements

• A Bachelor’s degree in life sciences, public health, clinical research, or a related discipline.

• A minimum of 2 years of experience in clinical research coordination, clinical operations, or a similar role.

• Knowledge of IRB processes and human subjects research regulations.

• Strong organizational capabilities and attention to detail across multiple simultaneous projects.

• Proficient in managing timelines, documentation, and effective communication with stakeholders.

• Comfortable in a fast-paced, early-stage environment with changing processes.

• Exceptional written and verbal communication skills.

• Prior experience in a dynamic startup setting.

• Experience in biotech, diagnostics, digital health, or similar startup environments is preferred.

• Background in pediatrics, maternal-infant health, or microbiome-related research is preferred.

• Familiarity with electronic data capture systems, clinical trial management systems, or REDCap is preferred.

• Experience coordinating with external partners, sites, or CROs is preferred.

• Work experience in direct-to-consumer health/wellness companies is preferred.

• Experience working remotely and proficiency in Slack is preferred.

• Self-motivated, proactive, and able to navigate ambiguity is preferred.

🏝️ Benefits

• Remote-first work environment.

• Flexible core hours, adjustable by up to two hours in either direction.

• Purpose-driven work focused on microbiome science and personalized health.

• Flexibility offered to support employees, including those with children.

• Opportunities for accelerated growth and a broader scope in a venture-scaled organization.

• A transparent culture with no surprises and real-time feedback.

• A collaborative, international work setting.

• Full-time employment opportunities available in North America.