Reports to: Senior Director, Clinical Research

Location: Remote

About the Company

Delve Bio is on a mission to improve patient outcomes and lower healthcare costs by bringing cutting-edge genomic technology to infectious diseases. We are a well-funded biotech company backed by some of the most experienced operators and investors in the industry. Our co-founders are highly experienced researchers, clinicians, and entrepreneurs, including Dr. Matthew Meyerson, MD. PhD (Director of Cancer Genomics at Broad Institute and co-founder of Foundation Medicine) and Dr. Joseph DeRisi, PhD (Professor at the University of California San Francisco and President of the Chan Zuckerberg Biohub). Delve Bio launched its flagship metagenomic next generation sequencing platform Delve Detect in 2024, providing game-changing, infectious disease testing to patients across the US.

About the Role

Reporting to the Senior Director of Clinical Research, this role is critical to the successful execution of clinical studies designed to demonstrate the clinical utility and analytical performance of Delve’s products. The Clinical Study Coordinator will collaborate closely with cross-functional teams, clinical sites, collaborators, and external stakeholders to ensure studies are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards.

This position is primarily remote, with up to 20% travel for study site visits within the continental US.

Responsibilities

Study Management:

• Organize and track new and ongoing collaborative studies, investigator-initiated studies, clinical study protocols and associated participant enrollment.
• Ensure clinical study timelines, deliverables, and budgets are met.
• Lead clinical research specimen repository management and tracking as well as build infrastructure as needed.

Site Coordination:

• Serve as a point of contact for clinical study sites, and / or CROs to address queries and provide guidance on study procedures.
• Facilitate site selection / feasibility, initiation / training, monitoring, and close-out activities in both remote and in-person capacities.
• Assist with establishing agreements, plans, and budgets for supporting clinical research studies.

Documentation and Reporting:

• Assist in the development and maintenance of study protocols, informed consent forms (ICFs), case report forms (CRFs), study reports, presentations, updates for internal and external stakeholders, and standard operational procedures (SOPs) as needed.
• Maintain study documentation (e.g., investigator site files, regulatory binders, participant records, case report forms) to ensure compliance with applicable regulations and guidelines.
• Assist in the preparation and submission of documentation, including IRB submissions, renewals, safety reporting, study amendments.

Data Management:

• Oversee the collection, review, and entry of clinical data to ensure accuracy and completeness.
• Collaborate with the data managers to resolve data discrepancies.

Vendor and Stakeholder Communication:

• Provide regular updates on study progress, milestones, and challenges to internal stakeholders.
• Coordinate with external vendors, such as reference laboratories or CROs, to ensure quality and timely deliverables.
• Support communication and coordinate meetings with investigators and key opinion leaders (KOLs).

Requirements

Education and Experience:

• Bachelor’s degree in life sciences, health sciences, or related field
• Minimum of 4 – 5 years of experience in clinical research at an Industry Sponsor or CRO, preferably in clinical diagnostics with IVD or laboratory-developed tests
• Familiarity with GCP, ISO 14155, CLIA, CAP, and other applicable US and international regulatory guidelines for IVDs and laboratory-developed tests
• Certification as a Clinical Research Coordinator (CCRC) or equivalent

Skills:

• Strong organizational and time management skills with the ability to handle multiple priorities
• Excellent communication skills, both written and verbal
• Detail-oriented with a proactive approach to problem-solving
• Familiarity with electronic data capture (EDC) systems such as REDCap
• Proficiency in Google Workspace (Docs, Sheets, Slides, Drive) and Microsoft Office Suite (Word, Excel, PowerPoint)

Preferred Qualifications:

• Experience with IVD studies or clinical studies in regulated environments
• Experience in clinical studies for Infectious Disease diagnostics and / or metagenomic / molecular genomic diagnostics
• Experience working in fast-paced startup environments with a flexible and positive mindset

Equal Employment Opportunity

Delve provides equal employment opportunities to all employees and applicants for employment without regard to race, color, national origin, religion, sexual orientation, gender, gender identity or expression, age, veteran status, disability, pregnancy or conditions related to pregnancy, or genetics.

To apply, submit resume to careers@delve.bio.