Clinical Research Nurse Supervisor

Position Overview

As a leader on Aveanna’s Clinical Research team, the Clinical Research Nurse Manager provides oversight and guidance to ensure clinical trials are carried out according to individual approved protocols and to manage clinical research nurses or nurse supervisors in their day to day nursing personnel operations. Reporting to the Wellness Vice President of Clinical Operations, the clinical research nurse manager will complete clinical trial visits on-site with investigator teams, or in an off-site capacity, working remotely visiting patients’ homes, workplace, or other suitable safe locations.  The clinical research manager must ensure all clinical research work is completed in accordance with Good Clinical Practice (GCP) guidelines, Aveanna’s Code of Professional Conduct, Directives and other regulatory, national and local requirements.

Essential Job Functions

• Evaluate standards of care and establish new policies and update existing policies to lead the clinical research team in improving the standard of care for patients
• Interview, hire and train new clinical research nurses and/or nurse supervisors
• Develop short and long-term goals for the clinical research nurses and/or nurse supervisors in delivering quality patient care
• Coach and evaluate the performance of clinical research staff
• Complete complex trend analysis and provide regular reports detailing findings to Senior Leadership with recommendations for improving the quality of care
• Manage schedules and workloads for all clinical research nurses and/or nurse supervisors
• Monitor and maintain nursing and clinical activities in compliance with current policies and regulations
• Utilizing clinical expertise and nursing skills and knowledge, provide oversight and advice in difficult or long-term care situations
• Expert knowledge of trial protocol, Case Report Forms (CRFs/eCRF), off-site manual

(if applicable), supporting documents, procedures, and timelines to enable day to day

running of the trial including all relevant SOPs

• Communicate regularly and effectively with the appropriate research nurse project manager (RNPM), Research nurse manager, site staff and the Principal Investigator, to ensure a smooth and efficient flow of information
• Maintain accurate documentation including electronic transfer of data in accordance with clinical protocols and Aveanna/Illingworth SOPs throughout the trial, ensuring subject confidentiality, adhering to GCP and data protection requirements
• Attend or lead Site Initiation Visits (SIV) as required and any other necessary meetings, including multi-disciplinary, project management and client-facing meetings.
• Lead meetings to review trends, issues among nurses, nurse managers and develop plans to address any gaps or issues; follow up and modify action plans as needed   
• Oversee clinical research nurses and/or nurse supervisors team to coordinate and complete subject trial visits on- and off-site, providing oversight and direction where necessary.
• Ensure all trial related procedures and assessments are completed according to the protocol and relevant SOPs and that data is collected accurately
• Administer trial medication as per the protocol, and facilitate the safe storage, transfer, and accountability of trial medication in accordance with SOPs
• Review and update SOPs as appropriate
• Ensure proper processing, packaging, and dispatching samples, liaising with courier companies and organizations in line with project requirements and supporting documents
• Identify potentially eligible patients for research projects and develop plans to assist with patient recruitment into clinical trials providing information and support for those patients for on- and off-site care
• Ensure the accurate reporting of adverse events (AEs) and serious adverse events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) to the site team and relevant RNPM, providing support for any additional follow up that may be required
• Develop plans to promptly identify and report any suspected misconduct or fraud to proper internal and external authorities and companies
• Where performing duties on-site, responsibilities may include those above and the following:

• Assisting clinicians in taking consent from subjects, or to take consent according to the

protocol

• Assist with the maintenance of Investigator Site files
• Facilitate and assist monitoring visits and source data verification (SDV) by liaising

with Investigators, multi-disciplinary research team and Client Company

representatives (e.g., Clinical Research Associate (CRA), auditor)

• Provide support to obtain regulatory approvals e.g., completion and submission of

Research Ethics Committee applications and amendments and local site approvals

• Administer research interventions; collect patient data according to protocol specification; evaluate the patient response to therapy; and integrate evidence-based practice into nursing practice
• Provides oversight of care to acute and complex patient populations and utilizes appropriate professional judgment and critical decision making in planning and providing care
• Demonstrate mastery of all nursing skills and associated technology for clinical trial(s)
• Appropriately oversee the execution of the Statement of Work (SOW), including the ability to take human samples I.e. blood, urine, nasal, nasopharyngeal, other as appropriate
• Provides specialized skill in the administration of medications and fluids through an intravenous (IV) line, central line, or venous access port. Starting lines and maintaining IV access.
• Ensure all clinical research nursing staff adhere to proper biohazardous waste utilization, transport and disposal and maintain appropriate infection control standards and precautions, and the proper utilization of Personal Protective Equipment (PPE)

Minimum Requirements:

• Bachelor’s Degree in Nursing preferred
• Active and in good standing nursing license; Registered Nurse with a minimum of 5 years post qualification experience. Adolescent and adult experience required; pediatric experience preferred.
• Minimum of two years of management experience
• Experience and knowledge of clinical research nursing skills such as venipuncture, IV administration (PICC lines, Port-a-cath, Central lines etc.) and ECG/EKG preferable
• Meets professional nursing standards and has expert knowledge of applicable local, state, and federal requirements
• Strong therapeutic communication and written skills
• Good computer skills and working knowledge of MS Office Suite, including Outlook, Word, Excel, PowerPoint
• Strong organizational skills with attention to detail
• Flexibility and timeliness in completing assigned tasks
• Demonstrated experience leading nursing functions in a variety of healthcare settings
• Must be an independent, self-starter who takes full accountability for executing on essential job functions and does not require close supervision in order to determine priorities or for tactical execution of responsibilities.
• Highly organized, able to prioritize multiple job responsibilities and exercise critical thinking in a fast-paced, high-demand work environment.
• Demonstrate initiative and independent judgment
• Excellent leadership and organizational skills

Physical Requirements

• Must be able to travel up to 90% of the time
• Must be able to lift 50 pounds
• Must complete with OSHA’s Respiratory Protection Program I.e. N-95 respirator, face shields/goggles, gloves, gowns and if applicable, show coverings
• Must be able to sufficiently move equipment without assistance
• Prolonged walking, standing, bending, kneeling, reaching, twisting
• Must be able to sit and climb stairs
• Must have visual and hearing acuity

Environment:
Must be able to function in a wide variety of environments which may involve exposure to allergens and other various conditions
Possible exposure to blood, bodily fluids and infectious diseases

Other Duties
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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