Clinical Research RN - Clinical Research RN *Days ( M-F, 8a-5p ) - 40hrs/wk

General Summary

Under the supervision of the Director of Clinical Research, the Clinical Research Nurse supports clinical research studies conducted by principal investigator(s) at Metro Health. Coordinates and participates in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.

Requirements

• State of MI RN License required
• Bachelor Degree Required
• Bachelor degree required.
• Previous clinical research experience helpful.
• Bilingual (Spanish) helpful.
• Must be highly organized and able to multitask.
• Interact effectively and pleasantly with a diverse population.
• Able to review detailed data and make prompt judgments based on that data.
• Able to work efficiently and effectively under tight deadlines, interruptions and high work volume.
• Excellent written and verbal communication skills.
• Working knowledge of computer and their applications to the related field.
• Able to work independently as well as with a team.

Essential Functions And Responsibilities

• Coordinate and participate in clinical research studies conducted by principal investigator(s).
• Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
• Care for patient’s progress to include documentation and reporting of adverse events and unanticipated problems.
• Perform protocol-required clinical assessments and procedures within State of Michigan Registered Nurse scope of practice and per delegation of the principal investigator.
• Evaluate and interpret collected clinical data in conjunction with principal investigator(s) as appropriate; prepare oral presentations or written reports and collaborate on the preparation of manuscripts for publication.
• Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
• Adhere to study protocol guidelines, Clinical Trial Agreements, and budgets.
• Ensure compliance with SOPs, FDA (U.S. Food and Drug Administration), NIH (National Institutes of Health) and other applicable regulations.
• Develop appropriate regulatory reports and associated documentation.
• Maintain primary responsibility of a variety of regulatory tasks including: assess, complete and submit protocol related documents to the appropriate committees and Institutional Review Board.
• Maintain essential regulatory documents (to include current CVs, licenses, site laboratory certifications).
• Cookordinate Human Research Subject Training for personnel.
• Maintain database and system for patient enrollment data, patient files, statistical data and other information pertinent to studies.
• Perform quality assurance review of study and regulatory documents, submit findings and recommendations in writing.
• Participate in the audit process by preparing patients records and follow up as necessary.
• Participate in ongoing process improvement activities, make improvements in data management, and suggest programmatic improvements.
• Function as resource to others involved in planning, implementation and evaluation of clinical studies.
• Assist in training new personnel.
• Communicate and interact with peers and other departments in a manner that is viewed as having a positive effect on patient services.
• Interact effectively with patients/family members and demonstrate sensitivity in regards to cultural diversity, age specific needs and confidentiality.