This position is responsible for assisting with the overall conduct of clinical research studies.
The incumbent will provide support to Kaiser physicians participating in clinical research study setup, protocol adherence and closure processes.
Essential Functions:
- Assists with clinical trials research patient recruitment, consent and enrollment administration.
- Schedules patient visits and follows up with missed appointments/no shows, rescheduling within protocol visit windows.
- Provides direct nursing care for study subjects, including labs and clinical testing, i.e., ECGs.
- Performs accurate data collection, management reporting, timely communication of study-related changes and serious adverse events, with the study sponsor and the Georgia Region's Institutional Review Board.
- Ensures that clinical trials records and files are maintained in an audit ready manner, and are in compliance with federal and FDA regulations, Good Clinical Practice Guidance, and Kaiser Permanente policies and procedures.
- Maintains security procedures to protect patient identifiable information, and study inventory and materials.
- Utilizes appropriate patient safety techniques for handling, storage and shipment of biologics, and dispensing of medication.
- Serves as a liaison between the primary study site, Principle Investigator and study participants for assistance with questions, adverse events and communicating information.
- Assists with conducting protocol specific interventions.
- Consistently supports compliance and the Principles of Responsibility (Kaiser Permanente's Code of Conduct) by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non-compliance, and adhering to applicable federal, state and local laws and regulations, accreditation and licenser requirements (if applicable), and Kaiser Permanente's policies and procedures.
- Maintains access to protected health information (PHI) at the minimum necessary required to effectively perform the job responsibilities.
Qualifications:
Basic Qualifications:
- Licensed Practical Nurse (LPN)
- Current, Unrestricted, Georgia LPN License
- 5 Years Nursing Experience
- 1 Year Phlebotomy Experience
- 1 Year Clinical Trial Research Experience Involving Human Subjects
- Knowledge of institutional Review Board and Research Regulatory Requirements
- Data Entry and Reporting Experience on a Computer
- Demonstrated Flexibility and Adaptability in Changing Health Care Environments
- Experience as a Member of a Multi-Disciplinary Medical Team
Preferred Qualifications:
- Certification in Human Subjects Protection
- Certification in Biohazard Materials Transport
- Ambulatory Care Experience
- Patient Counseling or Health Education Experience
External hires must pass a background check/drug screen.
We are proud to be an equal opportunity/affirmative action employer.