Clinical Research Nursing Manager

Overview Clinical Research Nursing Manager - Full Time (Onsite) at Holy Name Medical Center. The Clinical Research Nurse Manager oversees the integrity, quality, and compliance of clinical trials in accordance with federal, state, local regulations, IRB approvals, and Holy Name policies. This position manages the daily operations of the ICR CRC staff and provides varied support to all initiatives. What You Will Do Under the supervision of the Director Holy Name Institute for Clinical Research, provide consistent oversight of daily activities of the Central Clinical Research Unit (CCRU) ensuring compliance with regulatory requirements. Also provide coordination and direct patient care for clinical research trials conducted by the CCRU. Oversee daily operations of the ICR, including management of up to 10 CRCs. Assist Director in management of staff, resources/allocation planning and performance assessments for clinical research, trials implementation, oversight and regulatory/compliance functions. Plan staffing needs on short- and long-term bases, adjust based on workload to maintain safe, efficient care. Assist with scheduling staff for optimal resource availability, evaluate acuity, and suggest adjustments as needed. Ensure credentialing, training, and maintenance of quality source documentation per ICH-GCP and FDA regulations while satisfying HIPAA and patient rights rules. Manage and evaluate onboarding/training for Clinical Research Nurses, Coordinators involved in therapeutic and non-therapeutic research. Support regulatory staff in maintaining regulatory documents per Holy Name ICR SOP and applicable regulations. Communicate and collaborate with study teams including internal/external parties, sponsors, PI, and study participants. Evaluate potential protocols for feasibility and resource requirements; collaborate with PI and Sponsor to establish, implement, and conduct clinical trials; recruit and maintain patients in trials. Work with the ICR Program Manager to process agreements (NDAs, Clinical Trials Contracts, Data Use Agreements, BAAs), budgets, and all documentation for start-up through closure. Assist in developing and implementing clinical research technology systems and infrastructure; develop dashboards for ICR activity metrics; assist with communications, social media, and ICR newsletter/website. Cultivate relationships with industry sponsors; maintain a database of contacts; attend relevant meetings. Develop and implement ICR policies and SOPs; collaborate with QA/QI to identify gaps and conduct audits; participate in study audits with industry/regulatory representatives. Oversee clinical research coordination and services in all therapeutic areas; directly manage programs as needed. Provide direct patient care as needed to meet clinical research needs; precept and mentor staff; ensure protocol compliance; administer investigational medications and perform patient assessments during visits. Provide patient education on medication dosage, administration, and disease treatment. Demonstrate flexibility to shifting priorities and rapid change; perform other duties as assigned. Education Qualifications Bachelor's Degree BSN required Experience Qualifications Minimum 5 years of recent clinical nursing in a hospital, clinic, or similar healthcare setting Minimum 5 years of experience as a clinical research nurse coordinator or manager 1-3 years of clinical trials research experience preferred Knowledge, Skills, And Abilities Nursing competency skills per scope of practice (vital signs, nursing assessments, ECG/EKG, phlebotomy, injections, etc.) Understanding of clinical research regulatory requirements such as ICH-GCP Detail oriented and meticulous in all aspects of work; strong follow-through and problem-solving skills Professional demeanor with strong communication skills for the public, physicians, and coworkers Ability to work well independently and in a team; strong interpersonal, managerial, customer service, and multi-tasking abilities Proficient in Google Drive and/or Microsoft Office; experience with electronic health systems and databases used in research Ability to work under pressure, multi-task, and meet deadlines Knowledge of GCP, and regulations including HIPAA Licenses and Certifications RN - Registered Nurse - State Licensure (NJ) required upon hire BCLS - Basic Life Support (American Heart Association) upon hire Holy Name is an Equal Opportunity Employer. We offer a comprehensive benefits package for full-time and part-time employees, including health, dental, vision, retirement, paid time off, and other programs. Final base compensation will be determined based on employment status, skills, education, and experience. Pay range: $150,010.00 - $187,491.00. Holy Name is a mission-driven facility rooted in the principles of its founders. If you are hired, your pay and benefits will reflect internal equity considerations and applicable policies. #J-18808-Ljbffr