Research Registered Nurse

GENERAL SUMMARY:

Responsible for safe and effective implementation of clinical trial protocols. Ensures that study protocols are conducted, documented and reported in accordance with the study protocol, standard operating procedures, ICH-GCP and all applicable regulatory requirements.

PRINCIPAL JOB FUNCTIONS:

1. Commits to the mission, vision, beliefs and consistently demonstrates our core values.
2. Recruits patients for clinical trials. Monitors and verifies subject eligibility for, and compliance with, protocols and monitors them in treatments, including long-term follow-up.
3. Assists with the preparation of Institutional Review Board (IRB) applications including protocol and informed consents and obtaining approval to conduct the study.
4. Maintains appropriate correspondence with the IRB, including adverse events, annual renewals, and protocol amendments.
5. Designs workflow procedures including study worksheets in accordance to study protocols and standard operating procedures.
6. Conducts telephone and in-person interviews to determine subject eligibility.
7. Schedules intake appointments to recruit subjects to study. Obtains informed consent and HIPAA authorization, conducts intake interviews and enrolls subjects.
8. Maintains source documents and regulatory documentation of clinical trials. Ensures quality of data on case report forms.
9. Monitors health and safety of subjects with frequent contact and ensures subject compliance with the study protocol.
10. Presents adverse event documentation to the Principal Investigator and sponsor where appropriate.
11. Provides information on studies to referring physicians and keeps them updated on their patients' status.
12. Creates and maintains database of subject information and generates reports and shipments of data to coordinating center as needed.
13. Prepares documents for review by sponsors, monitors, and regulatory authorities as necessary.
14. Participates in meetings with sponsors, monitors, and regulatory authorities as necessary.
15. Follows all HIPAA requirements and maintains patient confidentiality.
16. Performs other related projects and duties as assigned.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

1. Knowledge of computerized information systems including electronic health records, Microsoft Office products, and data collection systems.
2. Knowledge of clinical research study procedures and protocols.
3. Knowledge of general nursing theory, regulations, and practices in giving and evaluating patient care.
4. Knowledge of medications and their possible effects on patients.
5. Knowledge of professional nursing theory, regulations and practices in giving and evaluating patient care.
6. Knowledge of medical terminology and coding.
7. Ability to communicate effectively both verbally and in writing.
8. Ability to effectively organize and prioritize work projects and manage time.
9. Ability to incorporate diverse teaching strategies relating to documentation requirements to achieve quality management, clinical and operational goals.
10. Ability to facilitate change and manage projects through analysis, key end user engagement, and consensus building within an interdisciplinary environment.
11. Ability to assess, plan, implement and evaluate the clinical theoretical processes as they relate to patient care and technology.
12. Ability to problem solve and engage independent critical thinking skills
13. Ability to work independently, take direction and work collaboratively with others.
14. Ability to network and develop effective working relationships with all co-workers, clinical and non-clinical colleagues.
15. Ability to maintain regular and punctual attendance.

EDUCATION AND EXPERIENCE:

Current Registered Nurse licensure from the State of Nebraska or approved compact state of residence as defined by the Nebraska Nurse Practice Act. Bachelor's degree preferred. Minimum two (2) years of clinical experience required. Experience in clinical research, study coordination, data management and study development is preferred

OTHER CREDENTIALS / CERTIFICATIONS:

Basic Life Support (CPR) certification required. Bryan Health recognizes American Heart Association (for healthcare professionals), American Red Cross (for healthcare professionals) and the Military Training Network.

PHYSICAL REQUIREMENTS:

(Physical Requirements are based on federal criteria and assigned by Human Resources upon review of the Principal Job Functions.)

Characterized as medium work requiring exertion of 35 to 50 pounds of force occasionally, and/or up to 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects including the human body.