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:
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 the 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:
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 or Associates Degree with commitment to obtain BSN within 5 years of hire required.
Licensure Requirement:
Registered Nurse in the State of Ohio required.
Certifications:
CPR required.
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.
Skills:
Demonstrated proficiency in clinical nursing skills (i.e.: venipuncture IV starts and injections);
Understanding of medical terminology clinical trials preferred
Working knowledge of PCs word processing and data management software
Additional Physical Requirements performed but not listed above:
(not specified)
Accountability Working Knowledge (Meets Expectations) Accuracy and Attention to Detail Working Knowledge (Meets Expectations) Bachelors Degree C102 CardioPulmonary Resuscitation (CPR) Various Issuers Clinical Research Working Knowledge (Meets Expectations) Decision Making and Critical Thinking Extensive Experience (Meets Expectations) Effective Communications Working Knowledge (Meets Expectations) Managing Multiple Priorities Working Knowledge (Meets Expectations) N101 Registered Nurse Ohio Single State (RN) Ohio Licensing Center N103 Registered Nurse Ohio Parent Multistate License (RN) Ohio Licensing Center N104 Registered Nurse Out of State Multistate License (RN) Nursys NCH EBP Working Knowledge (Meets Expectations) Nursing Assessment and Care HNU Working Knowledge (Meets Expectations) Planning and Organizing Working Knowledge (Meets Expectations) Service Excellence Extensive Experience (Meets Expectations) Tolerance for Ambiguity and Stress Working Knowledge (Meets Expectations)
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
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Clinical Research Coordinator RN-Gene Therapy
