POSITION OVERVIEWWe are seeking a highly experienced, strategic yet hands-on Clinical Research Operations Leader to join our delivery team as a full-time, fully benefited employee. In this role, you will partner with a multi-location community hospital system to transform its research enterprise into a scalable, high-performing, world-class clinical research operation.
As the primary subject matter expert (SME), this leader will collaborate closely with the Vitalief delivery team to design and implement enterprise-level operational initiatives, with a strong emphasis on Non-Oncology programs and enhancing cross-system communication and coordination. A central focus of the role will be leading the operational build-out and execution of a Cardiovascular clinical trials pilot, including infrastructure development, staffing strategy, workflow optimization, and technology deployment.
KEY RESPONSIBILITIES - What Success Looks Like:- Successful design, launch and operational stabilization of a scalable Cardiovascular research pilot across multiple hospital campuses and ambulatory sites.
- Aligned research strategy with institutional priorities through close partnership with executive, clinical, and administrative leadership.
- Established standardized workflows, SOPs and enterprise-wide performance metrics for research operations.
- Strengthened investigator engagement and increased research participation across service lines.
- Established scalable infrastructure and service line activation frameworks, in collaboration with investigators and sponsors, to reduce study activation timelines, enhance start-up predictability, and support sustainable research growth.
- Successfully managed cross-functional initiatives within matrixed reporting environments and complex academic-clinical governance structures.
- Transition from opportunistic research conduct to a deliberate, strategic, and scalable clinical research enterprise.
QUALIFICATIONS- Bachelor's degree required; Master's degree in Clinical Research Administration, Public Health, Nursing, or related field strongly preferred.
- Minimum of 7 to 10 years of progressive clinical research operations experience, including 3 to 5 years in leadership or management roles.
- Experience building and launching a clinical research multi-location operation from scratch, enabling timely initiation of multiple studies across diverse therapeutic areas.
- Demonstrated experience leading and supporting complex multi-site clinical research settings, including academic medical centers, affiliated and non-academic health systems, and disparate research locations.
- Demonstrated experience managing complex drug, device, adaptive, or multi-arm trials.
- Cardiovascular clinical research experience strongly preferred.
- Expertise in study start-up optimization, IRB processes, and regulatory compliance.
- Experience with CTMS platforms (e.g., OnCore) and Epic research integration.
- Strong knowledge of research billing compliance and Medicare clinical trial requirements.
- Proven ability to develop SOPs, quality systems, and performance dashboards.
- Experience strong relationships with sponsors and CRO partners to enhance site reputation and repeat business opportunities.
- Strong executive presence with the ability to influence across matrixed environments.
- Demonstrated success leading operational transformation or research program development initiatives.
PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.
IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.#LI-DNP
