While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, the Clinical Research Nurse oversees, facilitates and participates in the conduct of daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations.
The Clinical Research Nurse acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others.
By performing these duties, the Clinical Research Nurse works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.
Participate in the conduct of clinical research trials in the Section of Nephrology.
Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.
Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
Serve as a resource person or act as a consultant within area of clinical expertise.
Act as a leader within the department/unit through improving clinical research practice and serving as a resource.
Maintain working knowledge of current protocols, and internal SOPs.
Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
Provide Investigators with guidance regarding protocol requirements.
Maintain regulatory documentation.
Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
Provide direct supervision of other research staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
Attend continuing education and training opportunities relevant to job duties.
Applies logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Interprets information from caregivers, nurses, or physicians about patient condition, treatment plans, or appropriate activities.
Performs other related work as needed.
Certification in Principles and Practice of Clinical Research or similar training Â Â
Fundamental working knowledge of clinical research.
Knowledge of patient care fundamentals, including aseptic principles and techniques.
Ability to provide direct patient care in a professional and respectful manner.
Ability to exercise discretion and confidentiality while handling sensitive situations.
Ability to read medical documents and instruments.
Ability to train junior coordinators.
Ability to participate in protocol review and clinical trials evaluations.
Excellent interpersonal skills.
Excellent verbal and written communication.
Strong data management skills and attention to detail.
Ability to handle competing demands with diplomacy and enthusiasm.
Ability to work collaboratively with faculty and divisional clinical research infrastructure.
Excellent time management and ability to prioritize work assignments.
Ability to read and understand clinical trials protocols.
Familiarity with medical terminology/environment.
Working knowledge of Good Clinical Practices (GCP).
Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.
Research certification (e.g., SoCRA, ACRP, Graham School Clinical Trials Management & Regulatory Compliance). Â
Cover Letter (required)
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