Typical Schedule: Day Shift MondayFriday 40 hrs/week
This position works with adults and children that have neuromuscular diseases. Studies are generally multiyear studies which allows for building relationships with families that are participating in the trials. Description Summary:
Oversees the orientation day to day supervision and continuing professional development of team members through ongoing guidance and support in all aspects of conducting clinical research projects. Works with the study physician to ensure all patients involved in a clinical research trial are managed uneventfully safely and as effectively as possible through their episode of care and participation in the clinical research trial ensuring patient care is not compromised while participating in a clinical research trial. Manages all elements of a clinical research trial in order to meet all protocol obligations while following 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.
Job Description:
Essential Functions:
Works with Director to manage all human and physical resources associated with the research unit; Establishes performance quality and training standards for CRS clinical staff to ensure all unit research is conducted in compliance with all regulations
Provides guidance/oversight to team members in all aspects of clinical study coordination as well as patient safety; troubleshoots clinical study issues including those issues that have operational compliance and/or regulatory impact
Plans implements educates and evaluates care plan using EvidenceBased Practices in accordance with the requirements of the study protocol
Provides nursing care using a Family Centered approach throughout their clinical study participation while maintaining quality and safety as a priority. Delegates directs oversees and provides developmentally appropriate patient care. Practices professional nursing and promotes patient advocacy in accordance with the ANA Code of Ethics for Nurses and maintains a current Ohio Nursing License
Collaborates effectively and communicates patient care needs/expectations/priorities related to clinical trial participation to all involved care providers including unit nursing 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
Completes and manages all procedural data regulatory and training elements associated with clinical research project implementation and close out to ensure participant safety data integrity and compliance with all applicable regulations.
Education Requirement:
BSN required.
Licensure Requirement:
Registered Nurse in the State of Ohio required.
Certifications:
CPR required.
Must be willing to obtain and maintain NRP and PALS certification as determined by management.
Certification by the Association of Clinical Research Professionals or Society of Clinical Research Administrators or able to obtain within 6 months of hire.
Skills:
Demonstrated proficiency in clinical nursing and teaching clinical nursing skills such as venipuncture IV starts and injections
Understanding of medical terminology and clinical trials preferred
Working knowledge of PCs word processing and data management software
Additional Physical Requirements performed but not listed above:
(not specified)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals 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 their supervision. EOE M/F/Disability/Vet
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
Clinical Research Coordinator RN Lead- Gene Therapy
