Director, Clinical Research Operations – Service Line Activation

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $160k - $190k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

Where this job comes from

Posted on Vitalief Inc.'s careers page, not through a job board

First seen by Remote Rocketship 1 minute ago

Logo of Vitalief Inc.

Vitalief Inc.

51 - 200 employees

💼 Consulting

📦 Logistics

🏭 Manufacturing

💰 $2M Venture Round on 2023-04

Consulting • Logistics • Manufacturing

Vitalief Inc. is a company dedicated to transforming the clinical trial landscape by improving the value and contribution of trial sites throughout the drug development lifecycle. They specialize in offering consulting services, functional service provision (FSP), and workforce solutions to streamline clinical trials, enhance patient outcomes, and deliver value for Sponsors, Contract Research Organizations (CROs), and sites. With a focus on site operations and patient care in the life sciences, Vitalief serves academic sites, community health systems, independent sites, site networks, sponsors, and CROs. Their services address challenges in research and clinical trials, providing end-to-end solutions like strategic planning, resourcing models, training, and operational solutions. Vitalief is committed to delivering more efficient, high-quality clinical trials and driving innovation in the research industry.

📋 Description

• Lead discovery and develop the service line's research strategy, priorities, and study portfolio • Incorporate lessons learned from prior service-line launches into the activation framework • Identify and cultivate clinical champions and establish research leadership relationships • Engage department chairs, division chiefs, and clinicians • Build the investigator bench by identifying and developing new PIs/Sub-Is • Pair new investigators with experienced investigators • Lead the service line expert working group and establish its regular cadence • Identify and resolve cross-study bottlenecks • Steward priority studies from startup through enrollment • Escalate enterprise-level issues as needed • Align coordinator staffing and shared resources with the study portfolio, investigator capacity, and anticipated demand • Determine when dedicated service-line resources are warranted • Serve as the primary service-line contact for study opportunities and investigator relationships • Triage opportunities into the enterprise intake process • Partner with business development and feasibility teams on sponsor and CRO engagements • Represent investigators, sites, and patient populations accurately • Navigate institutional feasibility, IRB, contracting, budgets, coverage analysis, and research billing across both institutions • Track and report study volume, site distribution, startup milestones, and enrollment against commitments • Capture lessons learned and improve the activation playbook and processes • Prepare the function for transition to a permanent owner • Collaborate with the Vitalief delivery team, service-line clinical leadership, and the health system's clinical trials office

🎯 Requirements

• Bachelor's degree required • Master's degree in Clinical Research Administration, Public Health, Nursing, or a related field strongly preferred • Minimum 10 years of progressive clinical research operations experience, including 5 years in leadership or management roles • Experience building or activating a research service line, department, or multi-site program in an academic medical center or affiliated health system, with a record of opening studies on sponsor timelines • Required cardiovascular, pulmonary, or cardiopulmonary clinical research experience • Track record running industry trials in cardiology and vascular medicine, pulmonary or critical care medicine, or across both • Track record of building research programs from thin starting conditions • Demonstrated success recruiting, onboarding, and mentoring new principal investigators • Expertise in study startup optimization, institutional feasibility review, IRB and single-IRB reliance, Medicare coverage analysis, and research billing compliance • Experience with CTMS platforms, preferably OnCore, and Epic research integration • Ability to pull study and enrollment data and build a baseline • Working relationships with sponsors and CROs • Practical understanding of how sites win repeat awards • Ability to operate within a matrixed, dual-institution governance structure • Strong executive presence and clear written communication • Comfortable presenting to steering committees and service line clinical leadership • Ability to travel up to 10% • Must currently live within the USA and be open to traveling up to 10% domestically • Must have or be able to demonstrate a Bachelor's degree • Must not require visa sponsorship currently or in the future

🏖️ Benefits

• 20 PTO days • 9 paid holidays • Company-paid life insurance • Short- and long-term disability coverage • 401(k) retirement plan • Comprehensive healthcare benefits • Performance-based incentives • Equity participation • Primarily remote work • EST Zone work hours

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