Clinical Research Specialist-RN - Research/Projects - Sharp Mary Birch - FT 0.9 - 8hr Days

Sharp HealthCare•San Diego, CA

About The Position

Organizes, coordinates, and facilitates multidisciplinary research practice while promoting safe and appropriate research in accordance with state and federal regulations. Abstracts medical record information and supervises data abstraction for retrospective analysis, provides consultation on research design, methods, and statistical analysis, and maintains knowledge of research projects to facilitate their success. Provides progress reports, direct and indirect research services to patients and families, and mentorship and resources to people participating in research at the facility. The role coordinates research studies from patient screening and recruitment through study completion. It supports investigators and clinical staff with protocol implementation, monitors compliance with IRB standards and study parameters, coordinates study visits and procedures, manages research documentation and data queries, and communicates adverse events according to protocols and regulatory standards. The specialist also advocates for patients and families participating in studies and may conduct independent perinatal research as a principal investigator.

Requirements

Bachelor's degree: BSN or bachelor's degree in a health-related field; alternatively, an associate's degree in nursing.
At least 3 years of relevant clinical experience as a registered nurse.
At least 3 years of prior clinical research experience.
California Registered Nurse license from the California Board of Registered Nursing.
AHA Basic Life Support for Healthcare Professionals certification from the American Heart Association.
Expertise in good clinical practice techniques and advanced clinical skills relevant to assigned research.
Knowledge of medical terminology, advanced clinical research methodology, and data analysis techniques.
Excellent documentation skills and advanced written and verbal communication skills.
Good decision-making abilities and a friendly, positive, caring approach toward clients.

Nice To Haves

Master's degree in a health-related field.
Certified Clinical Research Coordinator (CCRC) credential from the Association of Clinical Research Professionals.

Responsibilities

Screen, recruit, and evaluate patients for study participation according to research protocols.
Serve as a liaison among patients, the hospital, physicians, and study personnel during assigned studies.
Coordinate patient visits, study procedures, sponsor site visits, and communications about research protocol progress.
Evaluate patients at research study visits and communicate findings to physician investigators.
Conduct or delegate chart reviews to assess study compliance and results; supervise completion of research data queries by required deadlines.
Provide clinical research monitors with required documents and prepare study records for long-term storage after study completion.
Support patients and families in understanding study protocols and objectives, assist with study-related requirements and procedures, and participate in informed consent.
Represent patient perspectives and respond to patient and family needs during research participation.
Review proposed research protocols for study design, sampling, scientific merit, logistics, and appropriateness; contribute to evaluating the feasibility of new studies.
Provide consultation and training to investigators on study design, sample size calculations, statistical analysis, data collection, and scientific writing.
Implement patient recruitment strategies and share research updates and results with investigators and site coordinators at participating institutions.
Conduct independent research studies as principal investigator, including sample size and power calculations, statistical analysis, interpretation, presentation, and publication of findings.
Assist investigators in meeting contracted patient enrollment targets using protocol inclusion and exclusion criteria.
Validate clinical staff understanding of research responsibilities and documentation requirements.
Monitor study protocol implementation in accordance with IRB standards and study parameters, including studies primarily assigned to another research nurse.
Dispense and control research study drugs in accordance with FDA regulations.
Perform or supervise study-specific procedures, such as EKG, treadmill, phlebotomy, and hospital procedures.
Maintain or supervise accurate flow sheets, case reports, databases, and study logs, including screening, enrollment, and drug dispensing and return logs.
Document and communicate adverse events according to research protocols and regulatory standards.
Act as a protocol resource for specialists and clinical staff participating in research studies.
Submit progress reports related to job responsibilities.