Director, Clinical Research Operations Service Line Activation

Vitalief•New Brunswick, NJ

1d•$160,000 - $190,000•Remote

About The Position

Vitalief is seeking an experienced, hands-on clinical research operations leader to activate a new research service line for a multi-location health system and its affiliated academic medical center. The two institutions are building a shared clinical research enterprise. The first service line is live and led, and this role leads to the next one, drawing on the playbook and enterprise capabilities that first activation is putting in place. The next service line is being selected now; cardiovascular, pulmonary, and cardiopulmonary programs are among those under consideration, and we are seeking candidates whose experience spans one or more of those areas. As the primary subject matter expert for the service line, you will collaborate closely with the Vitalief delivery team, the service line's clinical leadership, and the health system's clinical trials office. You will run discovery, set the service line's research strategy, seat and lead its working group, select and steward a priority study portfolio, build the investigator bench, and plan coordinator staffing.

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.
Cardiovascular, pulmonary, or cardiopulmonary clinical research experience is required: a track record running industry trials in cardiology and vascular medicine (drug, device, structural heart, heart failure, or cardiometabolic trials), in pulmonary or critical care medicine (Phase 2 and 3 drug studies, inhaled and biologic therapies, device and interventional pulmonology, or ICU trials), or across both.
Track record of building research programs from thin starting conditions: no dedicated research staff, no formal research leadership, investigators working around institutional barriers rather than through them. Comfortable operating without a full mandate and earning one through results.
Demonstrated success recruiting, onboarding, and mentoring new principal investigators, including early-career clinicians taking on their first industry studies.
Expertise in study startup optimization, institutional feasibility review, IRB and single-IRB reliance, Medicare coverage analysis, and research billing compliance.
Experience with CTMS platforms (OnCore preferred) and Epic research integration; comfortable pulling your own study and enrollment data and building a baseline from it.
Working relationships with sponsors and CROs and a practical understanding of how sites win repeat awards.
Demonstrated ability to operate within a matrixed, dual-institution governance structure: knowing which table an issue belongs at and getting it there with the facts needed for a decision.
Strong executive presence and clear written communication; comfortable presenting to steering committees and service line clinical leadership.

Nice To Haves

Master's degree in Clinical Research Administration, Public Health, Nursing, or a related field strongly preferred.

Responsibilities

Lead Service Line Strategy & Activation: Lead service line discovery and develop the strategy, priorities, and study portfolio using the established activation framework and incorporating lessons learned from prior launches.
Build Clinical Leadership & Investigator Capacity: Identify and cultivate clinical champions, establish research leadership relationships, and engage department chairs, division chiefs, and clinicians. Build the investigator bench by identifying and developing new PIs/Sub-Is and pairing them with experienced investigators.
Manage Portfolio & Working Group: Lead the service line expert working group, establish regular cadence, identify and resolve cross-study bottlenecks, and steward priority studies from startup through enrollment, escalating enterprise-level issues as needed.
Optimize Staffing & Resources: Align coordinator staffing and shared resources with the study portfolio, investigator capacity, and anticipated demand, determining when dedicated service line resources are warranted.
Manage Opportunities & Sponsor/CRO Engagement: Serve as the primary service line contact for study opportunities and investigator relationships. Triage opportunities into the enterprise intake process and partner with business development/feasibility teams on sponsor and CRO engagements, accurately representing investigators, sites, and patient populations.
Drive Activation, Performance & Reporting: Navigate institutional feasibility, IRB, contracting, budgets, coverage analysis, and research billing across both institutions while maintaining established enterprise processes. Track and report study volume, site distribution, startup milestones, and enrollment against commitments.
Continuous Improvement & Transition: Capture lessons learned, improve the activation playbook and processes, and prepare the function for transition to a permanent owner.