Clinical Research Nurse Coordinator- Allergy & Rheumatology

Department:
SOM KC Internal Medicine - Allergy, Clinical Immunology and Rheumatology

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Medicine - Allergy Immun Rheum
Position Title:
Clinical Research Nurse Coordinator- Allergy & Rheumatology
Job Family Group:
Professional Staff
Job Description Summary:
The division of Allergy and Clinical Immunology and Rheumatology is searching for a part-time Clinical Research Nurse Coordinator.
The Clinical Research Nurse Coordinator provides professional nursing care and patient monitoring for clinical trial participants. Works collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of less complex clinical research. Conduct a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors participant’s progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols.
Job Description:

Job Duties:

• Plan, provide, and document professional nursing care utilizing the nursing process for patients in accordance with physician orders, institutional SOPs and state licensure scope of practice. Use professional nursing judgment when conducting nursing research activities to participants.
• Assure that all professional nursing care provided is conducted in accordance with all KUMC and other regulatory requirements and is in accordance with the scope of practice for the nursing license held.
• Under the direction of Principal Investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials seeking guidance from Clinical Research Nurse Sr.
• Assist clinical staff with maintaining source documents and submit case report forms (CRFs) as required for clinical trials.
• Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
• Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
• Perform phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within KUMC policy.
• Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
• Prepare documentation and participate in study monitoring visits, reviews and audits.  Provide written and verbal reports to Principal Investigator and Project Manager, as required.
• Attend continuing education, research and training seminars as requested by manager.
• Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
• Other relevant duties as requested by the supervisor.

Required Qualifications:

Education:

• Associate’s degree plus two years related work experience OR an equivalent combination of relevant post-secondary education and work experience that equals at least 4 years.
• Must maintain at a minimum a LPN state license while in this position.

Skills & Competencies:

• Basic understanding of regulations governing clinical research
• (CFR, GCP, HIPAA)
• Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
• Superior communication, writing, organizational and presentation skills.
• Ability to Interact with multidisciplinary teams including physicians, administrative staff to assist in the meeting of the goals and objectives of the program or project are met.
• Ability to recognize competing priorities and deadlines and seek guidance in management of these where needed.

Preferred Qualifications:

• RN license
• Willingness to seek research certifications to further skills in the position.
• Provide clinical nursing skills with appropriate supervision based on license and experience.
• Interest in developing skills necessary to develop study budgets, contracts and grant applications

Preferred Research & Healthcare certification such as:

• Certified Clinical Research Coordinator (CCRC) or certification eligible
• Certified Clinical Research Professional (CCRP) or certification eligible

• Healthcare certifications preferred such as Basic Life Support (BLS) or Advanced Cardiac Life Support (ACLS) within 3 months of employment.

Employee Type:
Regular
Time Type:
Part time
Pay Rate Type:
Salary
Pay Grade:
A12
Pay Range:

Minimum

57572

Midpoint

73650

Maximum

89210

Department:
SOM KC Internal Medicine - Allergy, Clinical Immunology and Rheumatology

-----

Medicine - Allergy Immun Rheum
Position Title:
Clinical Research Nurse Coordinator- Allergy & Rheumatology
Job Family Group:
Professional Staff
Job Description Summary:
The division of Allergy and Clinical Immunology and Rheumatology is searching for a part-time Clinical Research Nurse Coordinator.
The Clinical Research Nurse Coordinator provides professional nursing care and patient monitoring for clinical trial participants. Works collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of less complex clinical research. Conduct a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors participant’s progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols.
Job Description:

Job Duties:

• Plan, provide, and document professional nursing care utilizing the nursing process for patients in accordance with physician orders, institutional SOPs and state licensure scope of practice. Use professional nursing judgment when conducting nursing research activities to participants.
• Assure that all professional nursing care provided is conducted in accordance with all KUMC and other regulatory requirements and is in accordance with the scope of practice for the nursing license held.
• Under the direction of Principal Investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials seeking guidance from Clinical Research Nurse Sr.
• Assist clinical staff with maintaining source documents and submit case report forms (CRFs) as required for clinical trials.
• Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
• Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
• Perform phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within KUMC policy.
• Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
• Prepare documentation and participate in study monitoring visits, reviews and audits.  Provide written and verbal reports to Principal Investigator and Project Manager, as required.
• Attend continuing education, research and training seminars as requested by manager.
• Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
• Other relevant duties as requested by the supervisor.

Required Qualifications:

Education:

• Associate’s degree plus two years related work experience OR an equivalent combination of relevant post-secondary education and work experience that equals at least 4 years.
• Must maintain at a minimum a LPN state license while in this position.

Skills & Competencies:

• Basic understanding of regulations governing clinical research
• (CFR, GCP, HIPAA)
• Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
• Superior communication, writing, organizational and presentation skills.
• Ability to Interact with multidisciplinary teams including physicians, administrative staff to assist in the meeting of the goals and objectives of the program or project are met.
• Ability to recognize competing priorities and deadlines and seek guidance in management of these where needed.

Preferred Qualifications:

• RN license
• Willingness to seek research certifications to further skills in the position.
• Provide clinical nursing skills with appropriate supervision based on license and experience.
• Interest in developing skills necessary to develop study budgets, contracts and grant applications

Preferred Research & Healthcare certification such as:

• Certified Clinical Research Coordinator (CCRC) or certification eligible
• Certified Clinical Research Professional (CCRP) or certification eligible

• Healthcare certifications preferred such as Basic Life Support (BLS) or Advanced Cardiac Life Support (ACLS) within 3 months of employment.

Employee Type:
Regular
Time Type:
Part time
Pay Rate Type:
Salary
Pay Grade:
A12
Pay Range:

Minimum

57572

Midpoint

73650

Maximum

89210