Clinical Research Nurse - 228281

OCCUPATIONAL SUMMARY

The Clinical Research Nurse I (CRN I) supports the clinical departments conducting research. The CRN I is primarily responsible for serving as the lead CRN carrying-out patient visits and serves as a bridge between the clinical staff / Principal Investigator (PI) and the research data and administration.

Responsibilities involve research patient care, research clinical services, data collection, data submission, adverse event identification and reporting, patient follow-up, records management, protocol regulatory management, quality assurance and other activities related to research and clinical care.

The CRN I works closely with the team to complete all research required services. Additionally, the CRN I will assist the Research Analyst to facilitate proper research patient registration and accurate billing.

PRIMARY DUTIES AND RESPONSIBILITIES

1. Coordinates, and performs, clinical procedures during research visits (i.e. vital signs, blood

draws, EKGs, drug administration, and other clinical activities as necessary and capable) in conjunction with appropriate training / certification and following hospital policy. Assists clinical

staff responsible for research patient visits complete the research requirements

2. Review and verify subject eligibility based on study inclusion / exclusion criteria.

3. Identify, recruit and screen potential clinical study participants.

4. Obtain informed consent from patients in coordination with the Investigator.

5. Leads the clinical research team in the identification, evaluation and reporting of all adverse

events and severe adverse events.

6. Support the team in obtaining, and disseminating, accurate clinical information essential for

completing Case Report Forms (CRF).

7. Synthesize clinical knowledge with protocol requirements to foster informed, protocol compliant,

decision-making in the best interest of patient safety and in coordination with the investigator.

Modifies treatment s per protocol.

8. Assure that all federal, state, local, and hospital laws and regulations are adhered to, as they relate to the protection of human subjects and to research compliance.

9. Provide backup coverage for other CRNs studies when necessary (travel to other sites may be

required).

10. Facilitate industry sponsored pre-study / initiation visits and provides sponsor monitor with

required site information.

11. Secure patient records and source documentation for sponsor monitoring and internal / external site audits.

12. Obtains, and maintains, database access. Enters data as needed.

13. Practices proper safety techniques in accordance with hospital and departmental policies and

procedures and immediately reports any mechanical or electrical equipment malfunctions, unsafe

conditions, or employee, patient, visitor injury or accident to the assigned Manager.

PROFESSIONAL DEVELOPMENT AND LEADERSHIP

1. Participates in and actively contributes to work groups, committees, process improvement

projects and other activities as necessary to maintain and advance knowledge and understanding

of clinical research and fulfill the mission and goals of the Clinical Research Department.

2. Complies with the Oncology Nursing Certification Corporation (ONCC) rules and regulations,

certification and registration requirements, standards of ethics and continuing education

requirements for oncology nursing professionals (as applicable in designated work area).

3. Complies with the Association of Clinical Research Professionals (ACRP) and / or the Society of

Clinical Research Associates (SOCRA) rules and regulations, certification and registration

requirements, standards of ethics and continuing education requirements for clinical research

professionals.

4. Complies with the Collaborative Institutional Training Initiative (CITI Program) rules and

regulations, registration requirements, standards of conduct and continuing education

requirements for research ethics, compliance and professional development.

ADDITIONAL DUTIES AND RESPONSIBILITIES

1. Working knowledge of Institutional and Federal Guidelines related to clinical research and Good

Clinical Practice (GCP)

2. Assists in providing clinical / operational feedback, if necessary to complete the Medicare

Coverage Analysis for studies

3. Other duties as assigned

The above statements are intended to describe the general nature and level of work performed by

people assigned to this classification. They are not construed to be an exhaustive list of all job

duties performed by the personnel so classified.

KNOWLEDGE SKILLS AND ABILITIES / LICENSE OR CERTIFICATION REQUIRED

1. Graduate of an accredited school of nursing with a Bachelor or Associate degree and (1) year

• relevant work experience in a clinical setting;
• Current and unencumbered licensure as a Registered Nurse in the State of Georgia
• Current and valid American Heart Association Basic Life Support (BLS) Provider CPR; AED Program card

2. If not Oncology Certified Nurse (OCN) at time of hire, must achieve professional certification

through the Oncology Nursing Certification Corporation (ONCC) by deadline assigned to

specific oncology work location.

3. If not Blood & Marrow Transplant Certified Nurse (BMTCN) at time of hire, must achieve

professional certifications through the Oncology Nursing Certification Corporation (ONCC) by

deadline assigned to specific bone marrow transplant work location.

4. If not Certified Clinical Research Coordinator (CCRC) or a Certified Clinical Research

Professional (CCRP) at time of hire, must achieve professional certification through the

Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research

Associates (SOCRA) by deadline assigned to specific work location.

5. Proficient in computer systems with expertise in use of Microsoft Office Suite, spreadsheets,

database and word processor applications

KNOWLEDGE SKILLS AND ABILITIES / LICENSE OR CERTIFICATION PREFERRED

1. Master of Science degree from an accredited college or university in a data driven research-

related field (such as nursing, allied health, biological sciences, chemistry, economics,

informatics, mathematics, psychology, sociology, epidemiology, public health).

2. Oncology Certified Nurse (OCN) through the Oncology Nursing Certification Corporation

ONCC).

3. Knowledge and understanding of clinical research healthcare science and Good Clinical Practice

GCP) international quality standards for clinical research.

4. Knowledge of clinical research practices including federal regulations, federal grant and clinical

trials policy and regulations, management systems and technology solutions used to coordinate

clinical research.

5. One (1) to three (3) years relevant work experience in a clinical or healthcare setting

6. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional

CCRP) through the Association of Clinical Research Professionals (ACRP) or the Society of

Clinical Research Associates (SOCRA).