Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this conference is to describe and define essential functions of the clinical research nurse with consideration of the ANA Scope and Standards of practice for Clinical Research Nursing. Clinical Research Nurses practice in a variety of clinical research settings, including serving as a bedside clinical research nurses, clinical research managers at a site, clinical research associates for a sponsor, or nurse researchers who are developing protocols and overseeing his/her own research. This program will address the unique challenges clinical research nurses face regarding the administration of clinical research and the care for patients. Packed with valuable insights, it's a must-attend for nurses, clinical staff, and managers across educational backgrounds aiming to enhance their understanding of Clinical Research Nursing.
Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research professionals with extensive experience in nursing, education and clinical research administration and management. Information will be presented and discussed regarding the American Nurses Association (ANA) scopes and standards of practice for clinical research nurses. This program will address the unique challenges clinical research nurses face regarding the administration of clinical research and the care for patients.
Learning Objectives: Upon completion of this course the attendee should be able to:
Discuss key concepts of the clinical trial process, along with an introduction to the Clinical Research Nursing Scope and Standards of Practice Guidelines, with associated competencies.
Discuss the various roles and responsibilities of the clinical research nurse.
Discuss the informed consent process with a small group practice session using case studies.
Discuss the start-up and ongoing management of clinical research projects.
Discuss facility capabilities listings to guide operational feasibility
Discuss considerations for leadership and management of the multidisciplinary clinical research team.
Discuss best practices related to study documentation.
Discuss considerations for clinical research program management.
Discuss as a group, best practices (templates, tools, workflow) related to project and program management, decentralized clinical trials, and professional development.
Discuss current industry trends, issues, and future directions.
Discuss clinical research nursing competencies from the professional practice standards and identify real-world application in various roles and associated responsibilities.