SUMMARY: The Research Nurse is responsible for the coordination, implementation and conduct of multiple research projects in the areas of hematology and oncology, fully integrated with applicable research management systems and processes, as well as the practice of nursing. This includes screening, recruitment, and enrollment of patients, as well as facilitating the consenting process. The individual will work under the principal investigator to coordinate, implement and monitor progress and completion of clinical studies/trials. They will assist in development of protocols, informed consent forms, manuscripts and clinical research forms as necessary, regulatory submissions, budgets, and payment tracking systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES: 1. Oversee the administrative functions of multi-site research studies.
2. Provides nursing care to research subjects enrolled in studies and maintains continual clinical assessment of research subjects.
3. Develops and maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA and IRB requirements.
4. Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to IRB, FDA, HSPC, HIPAA and other agency guidelines.
5. Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring.
6. Assists PI with research study design and development of research protocols.
7. May be responsible for research project budget development, identifying and classifying routine care vs. research related care, in addition to verifying that research protocol, research budget and research subject informed consent documents are consistent. 8. Manages the project within established time and participates with management to establish budgets and work within budget parameters. 9. Responsible for the IRB application for the department for both study initiation and renewal as well as preparation of contractual documents for IRB's and third party sponsors. 10. Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives. 11. Acts as liaison with Principal Investigators, pharmaceutical company representatives or other project funding organizations to monitor and update project progress. 12. Acts as liaison among physicians, research sponsors, nurses and ancillary personnel, and subjects to ensure proper adherence to research protocols. 13. Coordinates and participates in patient screening, recruitment and scheduling, initiating research patient records, administration of questionnaires, maintaining database Excel spreadsheets, completion of case report forms, performing data edits with P.I.'s research staff, pharmaceutical company monitors, etc. 14. Assists with clinical procedures, providing related patient care when required during data collection process. 15. May collate data, assist in data analysis or otherwise participate in organizing and determining project findings. 16. Establishes system for monitoring and maintenance of patient data records. 17. May provide technical support for the preparation of grant proposals, publications, presentations and special projects. 18. Participates in weekly research staff meetings. 19. Protects rights and research data of research volunteers, including medical records, data, etc. Obtain necessary consent forms, or HIPAA information forms as needed, in research process. 20. Performs other related duties as assigned or required. 21. Provide assistance with research project budget development, including identifying and classifying routine care vs. research related care. 22. Maintains system for monitoring and maintenance of patient data records. 23. May provide technical support for the preparation of grant proposals, publications, presentations and special projects.
Qualification Requirements/Preferences: Education Certifications/Licensure Experience Physical Abilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job requires a thorough knowledge of nursing techniques in area of research specialization. In addition, strong interpersonal skills are needed to work effectively with patients, their physicians and/or families; pharmaceutical company representative and other project personnel. Must demonstrate excellent communication skills, written and verbal, and have the ability to be consistently accurate, legible, and timely.
The position also requires the following: â¢ High energy with a focus on meeting deadlines; â¢ Able to prioritize and maintain progress on multiple scientific projects; â¢ Supportive of finding creative solutions to complex scientific and business challenges; â¢ Customer focused in a way that ensures desired outcomes are achieved; â¢ Collegial and highly participative at all levels; â¢ Focused on providing cutting edge technology that solves real business challenges and ultimately produces better treatment alternatives for patients.
EDUCATION and/or EXPERIENCE: Requires current California RN Licensure with five (5) years or more experience coordinating clinical research studies and clinical trials. Two (2) years experience in data management, experience in cardiology or transplant nursing, experience in federal grant proposal development and grant submissions, and knowledge of IRB clinical research application procedures preferred. Requires strong interpersonal skills to work effectively with patients, physicians, families, pharmaceutical companies, and other project personnel. Must demonstrate excellent communication skills, written and verbal. Certified Clinical Research Coordinator (CCRC) designation strongly preferred.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be able to lift 25 pounds, and stand and walk distances over the greater portion of the assigned shift.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.