Job description

ABOUT VITALIEF Vitalief is a consulting firm built exclusively for the research and clinical trial industry, providing innovative Consulting and Functional Service Provider (FSP) solutions to academic medical centers, health systems, sponsors, CROs, and site networks. By combining deep subject matter expertise with the experience of senior research practitioners, we help organizations accelerate study activation, optimize operations, improve financial performance, and build scalable workforce solutions that reduce costs, increase efficiency, and advance clinical breakthroughs for patients. POSITION SUMMARY Vitalief is seeking an experienced Clinical Research Operations Manager to join our team as a full-time employee supporting interventional oncology clinical trials at a premier research center in Somerset, NJ. In this highly visible role, you will oversee the successful execution of Phase II–IV oncology clinical trials, spanning multiple oncology disease groups, including Breast, GI/GU, Head & Neck, and Lung cancers. The ideal candidate thrives in a fast-paced, high-volume clinical research environment and is passionate about advancing cancer research while ensuring operational excellence, regulatory compliance, and the successful delivery of complex clinical trials. WHY VITALIEF? • Meaningful Impact: Support innovative oncology research that advances treatment options and improves patient outcomes. • People-First Culture: Join a collaborative environment focused on professional growth, innovation, and teamwork. • Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability coverage, a 401(k) retirement plan, and comprehensive healthcare benefits. • Work Location: Four (4) days on site in Somerset, NJ and one (1) day on site in Hamilton, NJ per week. • Schedule: Monday through Friday, 8:00 AM – 4:30 PM. • Salary Range: $115,000 to $150,000 depending on experience. RESPONSIBILITIES • Lead daily oncology clinical research operations across two outpatient hospital locations. • Oversee protocol implementation, study activation, enrollment, data collection, and research workflows. • Supervise, mentor, and develop a small clinical research team. • Support recruitment, onboarding, performance management, competency assessments, and professional development. • Ensure compliance with GCP, FDA regulations, OHRP, NIH, HIPAA, and IRB requirements. • Oversee regulatory submissions, documentation, record retention, and reporting of protocol deviations. • Develop corrective and preventive action plans to support continuous improvement. • Partner with investigators, research leadership, clinical teams, and institutional stakeholders to support research goals and priorities. • Participate in operational planning, resource management, and process improvement initiatives. • Lead meetings and multidisciplinary collaborations to enhance research performance and patient access to clinical trials. QUALIFICATIONS • Bachelor’s degree in Nursing, Health Sciences, Life Sciences, Public Health, or related field required; Master’s degree preferred. • 8 or more years of clinical research experience including 3 years of oncology clinical research experience. • Minimum of 1 to 2 years of supervisory experience managing clinical trials. • Registered Nurse (RN) preferred. • Experience working in an academic medical center, outpatient cancer center, or large healthcare system. • Knowledge of oncology clinical trial operations, protocol implementation, regulatory requirements, and research compliance standards, including GCP, FDA, OHRP, NIH, HIPAA, and IRB requirements. • Demonstrated ability to lead, mentor, and develop research teams in a complex clinical environment. • Strong project management, organizational, and time management skills with the ability to manage multiple priorities. • Experience with quality assurance activities, auditing, process improvement, and operational optimization. • Proficiency with Microsoft Office and clinical research systems, including CTMS, EDC platforms, and/or OnCore. • Excellent written, verbal, and interpersonal communication skills with the ability to collaborate effectively with physicians, research teams, and cross-functional stakeholders. • Strong critical thinking, problem-solving, decision-making, and relationship-building abilities. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. 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

Requirements

Must-haves

WHY VITALIEF? • Meaningful Impact: Support innovative oncology research that advances treatment options and improves patient outcomes.
People-First Culture: Join a collaborative environment focused on professional growth, innovation, and teamwork.
Work Location: Four (4) days on site in Somerset, NJ and one (1) day on site in Hamilton, NJ per week.
Schedule: Monday through Friday, 8:00 AM – 4:30 PM.
RESPONSIBILITIES • Lead daily oncology clinical research operations across two outpatient hospital locations.
Oversee protocol implementation, study activation, enrollment, data collection, and research workflows.
Supervise, mentor, and develop a small clinical research team.
Support recruitment, onboarding, performance management, competency assessments, and professional development.
Ensure compliance with GCP, FDA regulations, OHRP, NIH, HIPAA, and IRB requirements.
Oversee regulatory submissions, documentation, record retention, and reporting of protocol deviations.
Develop corrective and preventive action plans to support continuous improvement.
Partner with investigators, research leadership, clinical teams, and institutional stakeholders to support research goals and priorities.
Participate in operational planning, resource management, and process improvement initiatives.
Lead meetings and multidisciplinary collaborations to enhance research performance and patient access to clinical trials.
8 or more years of clinical research experience including 3 years of oncology clinical research experience.
Minimum of 1 to 2 years of supervisory experience managing clinical trials.
Experience working in an academic medical center, outpatient cancer center, or large healthcare system.
Knowledge of oncology clinical trial operations, protocol implementation, regulatory requirements, and research compliance standards, including GCP, FDA, OHRP, NIH, HIPAA, and IRB requirements.
Demonstrated ability to lead, mentor, and develop research teams in a complex clinical environment.
Strong project management, organizational, and time management skills with the ability to manage multiple priorities.
Experience with quality assurance activities, auditing, process improvement, and operational optimization.
Proficiency with Microsoft Office and clinical research systems, including CTMS, EDC platforms, and/or OnCore.

Nice-to-haves

QUALIFICATIONS • Bachelor’s degree in Nursing, Health Sciences, Life Sciences, Public Health, or related field required; Master’s degree preferred.
Registered Nurse (RN) preferred.

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Keywords to mirror

gcp

Platform: jazzhr
Effort: medium

Benefits

Benefits detected in the listing.

401(K)

Pto

Professional Development