Clinical Research Nurse Manager

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A Brief Overview
Under the leadership of the Medical Director of the CTSA CHOP Clinical Research Unit (CRU), this role will be a key member of the leadership team, responsible for providing operational, clinical and administrative oversight of all CRU Research Nursing Core patient care activities.

Specifically, this includes supervising all research nurses and the implementation of all research protocols in the CRU nursing unit and inpatient areas, as well as serving as a resource for all studies requiring nursing support. This position will ensure that all nurses are trained appropriately and that they are in compliance with state and hospital licensing and training requirements. This role will also assist in budgetary preparations and planning as well as annual reporting.

What you will do

Strategic Planning

• With the Medical leadership and administrative leadership, develop and implement short- and long-term plans for facilities and services to accommodate growth and complexity of the studies led by investigators
• Develop working relationships among investigators in different divisions and departments to facilitate the implementation of clinical studies under CHOP PI-sponsors or industry sponsors
• Ensure alignment of and communication with key stakeholders

Operational Management

• Provide operational, clinical and administrative oversight of patient care activities and coordinate resources for studies requiring nursing support
• Work collaboratively with other team members and leaders to review the resource requests and ensure that applications submitted by investigators requesting nursing core resources reflects what is needed in the IRB approved protocol
• Attend monthly operations meetings; make recommendations about level of nursing resources available
• Hold monthly nursing meetings to review activities, projected utilizations, schedules and any issues involving nursing requests or services
• Make recommendations to administrative and program leadership to resolve any nursing or patient care issues within the nursing areas
• Oversee nursing patient census records and reporting, ensure staff is keeping accurate records of protocol utilization and patient visit activities
• Assist in budgetary preparations and prepare the annual report to be shared with senior leaders
• Schedule and oversee implementation of studies to maximize resource allocation at family/patient convenience
• Work in the various nursing areas implementing current protocols, manage all protocols at the patient bedside
• Ensure safety of research subjects through communication and collaboration with the hospital and research safety teams
• Purchasing including Supply chain and COUPA; assist studies in purchases that are required

Investigator/Nursing Core Liaison

• Evaluation of research studies
• Understand diagnosis and pertinent medical findings, rationale, goals in treatment, and nursing care protocols
• Review plan of study with the nursing personnel to establish full understanding of the research protocol and to facilitate the research study
• Assist and/or oversees assistance given to investigators, in protocol development and planning by educating them on resources and activities
• Promote high quality clinical research through oversight, policy development and QA mechanisms
• Meets with investigators and/or nursing personnel prior to the implementation of study to ensure all necessary processes are clearly established prior to study initiation
• Attend educational sessions, conferences, or patient care rounds which are pertinent to current protocols
• Ensure that accurate, dependable data is relayed to investigators

Personnel Management

• Supervise all research nursing staff
• Assist the lab core leadership by support scheduling of laboratory and medical assistant staff
• Approve time off requests, complete performance evaluations, ensure adequate new employee and continuing training of staff, when necessary develop and implement job performance improvements goals and plans
• Create staffing plans and documents future staffing needs; justify additional staffing requests; ensure productivity of all staff
• Work with the administrative leadership in filling any vacant positions by reviewing current job description, reviewing candidate credentials, interviewing and making recommendations for hire
• Aim to retain experienced nursing staff; develop plans for nursing retention
• Utilize patient satisfaction data, QI data, incident report data and other forms of feedback to improve care provided by nursing staff
• Immediately investigate patient/family complaints and provide prompt feedback
• Supervise, and as needed perform, the insertion of IVs, drawing of blood samples, accessing ports, collecting biospecimens as designated by the protocol
• Coordinate and supervise all necessary services performed by nursing staff to complete study requirements and minimize disruption to patient/family; this can include ECGs, Holter monitors, IV infusions, oral and injectable medications and any other services in the protocol under nursing services
• Document study related activities in electronic health record including vital signs, urine pregnancy tests, medication dosing
• Provide support of the lab core and laboratory staff, including
  -Collaborate to set up studies in systems
  -Assist study staff in identifying samples that need to be pulled and sent out from systems
  -Review lab protocols with laboratory staff, including additives and special processing

Regulatory Compliance

• Oversee adherence to principles of infection control and universal precautions, adherence to OSHA standards, hazardous material guidelines, and isolation procedures
• Ensure all necessary licensing and training requirements are current and documented
• Distribute and track investigational medication
• Oversee with refrigeration systems - making sure units are checked, temperature probes are calibrated annually
• Prepare temperature logs and follow up on freezer or refrigerator alarms
• Oversee the NOVA glucose monitors including training and adding new lot numbers to the system for both the sticks and controls
• Reviewing POC, including yearly staff competency

Education Qualifications

• Bachelor's Degree Nursing Required
• Master's Degree Nursing Preferred

Experience Qualifications

• At least five (5) years of pediatric nursing experience Required
• At least three (3) years of leadership, management or supervisory experience Required
• At least two (2) years of clinical research experience including the conduct of clinical trials Preferred

Skills and Abilities

• Advanced proficiency with electronic medical records systems (EPIC)
• Intermediate proficiency with office software (Microsoft) including email & calendar, word processing, spreadsheet, presentation, collaboration and content/knowledge management software (Outlook, Word, Excel, PowerPoint, Teams, SharePoint)
• Advanced knowledge of policies and procedures, confidentiality, security, and privacy regulations regarding the use of clinical information systems.
• Excellent verbal and written communications skills
• Excellent interpersonal skills
• Excellent time management skills
• Excellent organizational skills
• Strong leadership skills
• Ability to maintain confidentiality and professionalism
• Ability to work independently with minimal supervision
• Ability to gather, analyze and make recommendations/decisions based on data / best practices
• Ability to convey complex or technical information in an easy-to-understand manner
• Ability to influence others to accomplish tasks outside of the direct span of control
• Ability to collaborate with stakeholders at all levels

Licenses and Certifications

• Registered Nurse (Pennsylvania) - Pennsylvania State Licensing Board - upon hire - Required or
• Registered Nurse (New Jersey) - New Jersey State Licensing Board - upon hire - Required

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SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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