Clinical Research Nursing Manager

Description
Manager, Clinical Research Nursing

Welcome to Holy Name, a medical center where innovation is not just a goal — it's a commitment. Here, medical excellence thrives, allowing hope to reign supreme and leaving no room for fear. At our hospital, every patient is cared for with undivided attention — because healing every soul is our sole focus.

Holy Name is New Jersey's only independent Catholic health system, comprising a 361-bed acute care hospital, a renowned cancer center, a state-of-the-art fitness center, a residential hospice, a prestigious nursing school, and an extensive physician network. Healing at Holy Name goes beyond medicine and technology – it is infused with faith, conviction, compassion, and a commitment to educating the next generation of healthcare professionals through a variety of residency and educational programs. Our mission to provide care for the body, mind, and soul spans education, prevention, diagnosis, treatment, rehabilitation, and overall wellness. This is at the core of who we are and what we do, and we've done it this way across generations, every single day, for nearly 100 years. Every innovation, medical breakthrough, and groundbreaking treatment is powered by some of the best minds in medicine, ensuring nothing is left on the table or the road to recovery.

A Brief Overview
The Clinical Research Nurse Manager, under the direction of the Director, Institute for Clinical Research (ICR) and guidance/supervision of the Principal Investigator (PI), ensures the integrity, quality, and compliance of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Holy Name policies and procedures. This position manages and oversees the daily operations of the ICR Clinical Research Coordinator (CRC) staff and provides varied support to all initiatives. See detailed description of job responsibilities below.

What You Will Do

• Under the supervision of the Director Holy Name Institute for Clinical Research, the Clinical Research Nurse Manager (CRNM) provides consistent oversight of daily activities of the Central Clinical Research Unit (CCRU) ensuring compliance with federal, state and institutional research regulatory requirements. The CRNM also provides coordination and direct patient care for clinical research trials/studies conducted by the CCRU.
• Oversees daily operations of the ICR, including management of up to 10 CRCs.
• Assist Director in the management of staff, resources/allocation planning and performance assessments for various clinical research, clinical trials implementation and oversight and regulatory and compliance functions. Plans for the staffing needs of the site(s) on a short- and long-term basis, adjusting based on workload and other staffing variables to maintain safe, efficient care in an effective manner. Assists with scheduling staff for optimal availability of resources, evaluating acuity of each service, suggesting adjustments as needed.
• Ensures appropriate credentialing, training and maintenance of good quality source documentation according to ICH-GCP guidelines and FDA regulations while satisfying HIPAA and patient rights, rules and regulations for the CCRU staff. The CRNM responsible for managing and continuously evaluating a comprehensive onboarding and training program to ensure the ongoing development of Clinical Research Nurses Coordinators and Clinical Research Coordinators involved in the conduct of both therapeutic and non therapeutic clinical research
• Supports the regulatory staff in the maintenance of regulatory documents in accordance with Holy Name ICR SOP and applicable regulations.
• Communicates and collaborates with study teams including internal and external parties, sponsors, PI, and study participants.
• Evaluates potential protocols to determine feasibility, resource requirements; Collaborates with PI and Sponsor in establishing, implementing, and conducting clinical trials; responsible for recruitment and maintenance of patients in clinical trials.
• Works with the ICR Program Manager to process and execute non-disclosure agreements, clinical trials contracts, Data Use Agreements (DUAs), Business Associate Agreements (BAAs), Coverage Analysis study budgets and all documentation required for study start-up and maintenance through closure.
• Assists in the development and implementation of clinical research technology systems and infrastructure. Works with the Special Projects Coordinator to develop dashboards for metrics on the status of ICR activity. Works with Program Manager on communications, social media and ICR newsletter and website.
• Cultivates and manages relationships with industry sponsors; develops a database of contacts in industry and other sponsors of clinical research; attends all relevant meetings.
• Develops and implements ICR policies and standing operating procedures (SOPs); works closely with the manager of Quality Assurance/Quality Improvement to develop QA/QI policies and SOPs and identify gaps and required for-cause/not-for-cause internal audits. Participates in study audits, in conjunction with industry or regulatory representatives. Implements new and amended standard operating procedures to staff under the supervision of the Directors.
• Oversees clinical research coordination and clinical services in all therapeutic areas. As needed, directly manages clinical research programs in therapeutic areas.
• Provides direct patient care as needed to meet clinical research care needs and precepts and mentors staff in care related tasks. Ensures compliance with each study's protocol; administers investigational medications and performs patient assessment during clinical visits.
• Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration and disease treatment.
• Demonstrates flexibility to shifting priorities and rapid change
• Performs 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 required
• Minimum 5 years of experience as a clinical research nurse coordinator or manager. required
• 1-3 years At least 1 year of clinical trials research experience preferred

Knowledge, Skills, And Abilities

• Nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG/EKG, phlebotomy, administering injections, etc.)
• Understanding of clinical research regulatory requirements such as ICH-GCP
• Detail oriented and meticulous in all aspects of work
• Strong follow through skills and ability to proactively identify and solve problems
• Demonstrated initiative is imperative
• Must have professional demeanor, strong communication skills with the public as well as physicians and co-workers
• Ability to work well independently as well as in team environment
• Strong interpersonal, managerial, customer service and multi-tasking skills are critical
• Proficient in Google Drive and/or Microsoft Office Word and Excel, electronic health systems and databases used in research environment
• Possess the ability to work well under pressure, multi-task, and manage deadlines
• Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures

Licenses and Certifications

• RN - Registered Nurse - State Licensure and/or Compact State Licensure Valid Registered Nurse license in state of NJ upon hire required
• BCLS - Basic Life Support American Heart Association upon hire required

At Holy Name, we believe in rewarding every team member with more than a paycheck—we invest in your future and well-being. Full-time and part-time employees have access to a comprehensive benefits package designed to support your health, financial security, and quality of life. We offer low-cost medical coverage with generous employer contributions, dental and vision plans, discounted prescriptions, and access to on-site child care. Additional benefits include 401(k) matching, tuition reimbursement, paid time off, flexible spending accounts, legal and voluntary coverage options, life insurance, and free on-site parking. If you are hired at Holy Name, your final base compensation will be determined based on factors such as employment status (Full/Part-Time or Per Diem) skills, education, and/or experience. In addition to those factors – we believe in the importance of pay equity and consider any internal equity of our current team members as a part of any final offer. Pay Range: $150, $187,491.00

Holy Name is a mission-driven facility whose quality standards and philosophy are rooted in the principles of its founders, the Sisters of St. Joseph of Peace. Those principles are exercised daily by the Medical Center's dedicated and talented staff members. Holy Name is an Equal Opportunity Employer.