Research Nurse Practitioner Clinical Lead

Manages advanced practice staff involved in clinical research and clinical trials, including direct patient care, resource management, training related to study protocols and professional development; ensures all operations follow applicable regulations: Code of Federal Regulations Good Clinical Practices (GCP) and International Conference on Harmonization GCP guidelines; state regulations and departmental/institutional standard operating procedures. In close partnership with the Administrative Direct and the Clinical Operations Manager, the NP Lead ensure that all participants involved in clinical research trials in the Gene Therapy Operations are managed uneventfully, safely, and as effectively as possible through their episode of care and participation in the clinical research trial, ensuring participant care is not compromised while participating in a clinical research trial or study. Practices within professional scope and promotes participant advocacy in accordance with the professional Code of Ethics and maintains a current Ohio Advanced License.

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* Directly responsible for the management and oversight of research NPs within the clinical research/inpatient/outpatients spaces and all clinical research projects conducted to ensure compliance with all applicable hospital and research regulations and policies, protection of human subjects, high quality data collection and effective study enrollment and completion.
* Provides guidance/oversight in close collaboration with the Clinical Operations Manager and Sr. Regulatory Coordinator in all aspects of clinical study coordination including resource and staff management as well as patient safety; troubleshoots clinical study issues including those issues that have operational, compliance and/or regulatory impact.
* Works closely with the Administrative Director and Business Project Manager to ensure staffing and clinical care resources are adequate and compliant with available clinical trial or study budgets.
* Assists investigators and clinical research staff in planning, implementing, performing, educating and evaluating care plans using Evidence-Based Practices in accordance with the requirements of the study protocol. Clearly documents and communicates information both in written and verbal forms
* Collaborates effectively and communicates participant care needs/expectations/priorities related to clinical trial participation to all involved care providers including GTO clinical staff, attending physician, ancillary service providers (radiology, cardiology, physical therapy, pharmacy, etc.) to facilitate positive patient outcomes both in clinical care and in clinical trial participation
* Works with Administrative Director to provide assistance to investigators with the development and feasibility of research proposals; working to write an effective proposal/protocol with all necessary components; review and make suggestions for revision
* Works with the GTO Training/Compliance and Regulatory Teams on the development and implementation of quality and training standards for Research NPs to ensure all research is in compliance with regulations.
* Responsible for planning and assigning NPs to various studies, making organizational and/or resource adjustments as appropriate; Responsible for hiring, training, performance evaluations and firing of Research NPs in collaboration with the Administrative Director and Clinical Operations Manager.
* Performs diagnostic and therapeutic procedures according to established guidelines and standards as necessary for the care of the patient; Utilizing evidence based practice, serves as a clinical expert for policies, procedures, documentation, and skills.
* Commits to continued professional development of self and others.
* Maintains current knowledge of federal, local and institutional hospital and research regulations by serving on hospital committees, reviewing current publications and attending conferences; Advises GTO leadership of regulation/policy changes and projected impact to clinical research operations.

Note: Regular, reliable and consistent attendance is an essential job function. Employees are expected to perform work as scheduled. Please see the
physical requirements and workplace exposures for this position listed below.

EDUCATION: Master of Science degree or equivalent provision

LICENSURE: Licensed as an Advanced Practice Registered Nurse (APRN) or Physician Assistant (PA) in the state of Ohio

CERTIFICATIONS: Maintains national certification as APRN in the appropriate population foci for the position, or PA

MINIMUM PHYSICAL REQUIREMENTS:

Must be able to see, hear, speak, read, and perform manual tasks with or without accommodation and care for oneself, with little or no difficulty.
• Performance of principal duties and responsibilities requires ability to travel.

The above list of duties is intended to describe the general nature and level of work performed by people assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the people so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.EOE M/F/Disability/Vet