Research/Regulatory Nurse Practitioner - Gene Therapy

1.0 FTE, 40 hours per week

Competitive benefits package & pay based on experience level

The Nurse Practitioner will function in accordance with the philosophy, policies, procedures and standards of NCH and functions within the APRN practice guidelines agreed upon by the medical and patient care services departments; as directed by the Principal Investigator (PI), this position performs all research patient management activities, specifically related to regulatory work, in conjunction with the Clinical Research Coordinators (CRCs) and co-Investigators (co-Is) on gene therapy trials. The Nurse Practitioner, in collaboration with the CRCs and Drug and Device Development Services (DDDS) staff, assists in the writing of FDA Annual Reports, OBA reporting, preparation of DSMB reports, and Clinical Study Reports. Works directly with CRCs, PI, and co-Is, on IRB submissions.

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1. Patient Management: functions within the APN practice guidelines. Works directly with PI, Co-I, CRCs, and study staff in research patient visits and follow-up. Performs a complete standard physical examination, and distinguishes between normal and abnormal findings.

2. Reviews laboratory and imaging reports to assess findings in context of study protocols.

3. Conducts preliminary review of complex research protocols that propose the use of human subjects. Reviews the protocol submissions for completeness, identifies problems, performs quality control, and checks for compliance with current federal regulations.

4. Serves as the primary resource for investigators regarding the organizational IRB review requirements for research protocols.

5. Reviews all adverse events prior to submission to regulatory oversight committees

6. Provides training to investigators and study staff regarding the submission of new protocols, adverse events, and amendments to existing protocols following organization policies.

7. Tracks pending applications and advises investigators on the status of their submission. Identifies and tracks approved research protocols, including implementing office established procedures to assist investigators in complying with conditions imposed by the regulatory committees.

8. Oversees clinical trial record maintenance and retention to comply with regulatory requirements

9. Attends regulatory professional meetings and surveys published literature for new or modified regulations that impact research on human or animal subjects.

10. Selects and orders tests and procedures necessary to for research protocols

11. Performs clinical and research procedures, according to established protocols, as required per study protocol or as standard care of the patient.

12. Clinical and research procedures may include: administration of investigational and standard medications; performance of invasive procedures such as venipuncture, IV insertion and injections, skin biopsy, or other as dictated by the protocols.

13. Documents and effectively communicates the plan of care and patient progress using Case Report Forms. Communicates the results appropriately to the PI or Co-PI.

14. Initiates consults to other services at the direction of their collaborating investigator.

15. If they have prescriptive authority, prescribing within the Ohio Board of Nursing formulary and the NCH formulary.

16. Functions in collaborative role with the professional nursing staff and other care providers sharing information and responding to concerns of the other care providers.
17. In conjunction with the PI, Co-Is, and CRCs: a. Meets patient/family needs identified in the research protocol and contributes to the protocol as appropriate. b. Meets specific emotional/support needs of research families and facilitates resolution of the parents' psychosocial concerns, initiating interdisciplinary involvement as indicated. d. Communicates with the research team data relevant to patient and or family needs.

18. Maintains clinical competency, and stays informed of current trends in their specialty and in nursing practice.

19. Remains informed of current research specific to the care of patients within their specialty, making this data available to staff and applying it as appropriate to clinical practice.

20. Identifies patient problems suitable for research, and cooperates with research activities within their specialty practice. Also reviews literature for evidenced base care or contribute to obtaining data.

21. Establishes professional objectives, evaluates self, and shares progress periodically with the Director.

22. Maintains involvement with professional nursing organizations or specialty organizations to promote collegiality and networking.

23. Contributes to the goals of the hospital, division and or specialty.

24. Assists in educating others regarding the role of the Research Nurse Practitioner.

25. Assumes other duties and responsibilities as assigned.

Reports to: Director of Center for Gene Therapy (K. Flanigan)

KNOWLEDGE , SKILLS AND ABILITIES REQUIRED

1. Master of Science Degree in Nursing or must fall under the grandfather clause for APNs

2. Registered Nurse with current licensure to practice nursing in the State of Ohio.

3. Certified by ACRP, SOCRA or equivalent

4. Certificate of Authority to practice as an Advanced Practice Nurse in the State of Ohio.

5. Certificate to prescribe

6. Minimum of three years nursing experience.

7. Demonstrates nursing competence with specific clinical skills and knowledge in their area of specialty.

8. Demonstrates leadership, interpersonal skills, teaching ability, advanced level of critical thinking and decision making.

9. Excellent verbal and written communication skills.

MINIMUM PHYSICAL REQUIREMENTS

1. Must be able to see, hear, stand, walk, speak, read and perform manual tasks with or without accommodation, and care for oneself with little or no difficulty.

2. Must be able to independently lift up to 25lbs.

3 Must be able to move or reposition patients of any weight or size with the assistance of another person(s) and /or equipment.

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 individual 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