POSITION SUMMARYVitalief 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.
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. 
