Clinical Research RN - Clinical Research RN *Days ( M-F, 8a-5p) - 40hrs/wk
University of Michigan Health-West
Wyoming, Michigan
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.
- Shift and hours
- Monday through Friday, 8:00 AM - 5:00 PM Clinical Research RN *Days ( M-F, 8a-5p ) - 40hrs/wk40 hours a week
- Unit and setting
- Clinical Research
- License
- RN license State of MI RN License requiredState of Michigan RN license
- Term
- Permanent FTE status: 11.0 FTE
Do you qualify?
- License
- State of Michigan RN license State of MI RN License required Check your license
- Education
- bachelor's degree Bachelor Degree Required
- Also asks
- highly organized and able to multitask Must be highly organized and able to multitask.
- Also asks
- interact effectively and pleasantly with a diverse population Interact effectively and pleasantly with a diverse population.
- Also asks
- ability to review detailed data and make prompt judgments Ability to review detailed data and make prompt judgments based on that data.
- Also asks
- work efficiently under tight deadlines, interruptions, and high work volume Ability to work efficiently and effectively under tight deadlines, interruptions and high work volume.
- Also asks
- excellent written and verbal communication skills Excellent written and verbal communication skills.
- Also asks
- working knowledge of computers and related applications Working knowledge of computer and their applications to the related field.
- Also asks
- ability to work independently and with a team Ability to work independently as well as with a team.
Preferred
- Experience
- clinical research experience
- Also asks
- bilingual in Spanish
The role and schedule
- Precepting
- You would precept other nurses Assist in training new personnel.
- Day to day
- coordinate and participate in clinical research studies Coordinate and participate in clinical research studies conducted by principal investigator(s).
- Day to day
- collect, compile, document, and analyze clinical research data Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
- Day to day
- collect data from medical records and other sources, and obtain lab specimens
- Day to day
- monitor patient progress and report adverse events Monitor patient’s progress to include documentation and reporting of adverse events and unanticipated problems.
- Day to day
- perform protocol-required clinical assessments and procedures Perform protocol-required clinical assessments and procedures within State of Michigan Registered Nurse scope of practice and per delegation of the principal investigator..
- Day to day
- evaluate clinical data, prepare presentations, reports, and manuscripts
- Day to day
- review scientific literature to aid study planning 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.
- Day to day
- adhere to protocol guidelines, CTAs, budgets, and regulations Adhere to study protocol guidelines, Clinical Trial Agreements, and budgets.
- Day to day
- ensure compliance with SOPs, FDA, and NIH regulations
- Day to day
- develop regulatory reports and documentation Develop appropriate regulatory reports and associated documentation.
- Day to day
- submit protocol documents to committees and IRB
- Day to day
- maintain essential regulatory documents Maintain essential regulatory documents (to include current CVs, licenses, site laboratory certifications).
- Day to day
- coordinate Human Research Subject Training Coordinate Human Research Subject Training for personnel.
- Day to day
- maintain patient enrollment database and study files Maintain database and system for patient enrollment data, patient files, statistical data and other information pertinent to studies.
- Day to day
- perform quality assurance reviews of study and regulatory documents Perform quality assurance review of study and regulatory documents, submit findings and recommendations in writing.
- Day to day
- prepare patient records for audits and follow up Participate in the audit process by preparing patients records and follow up as necessary.
- Day to day
- participate in ongoing process and data management improvements Participate in ongoing process improvement activities, make improvements in data management, and suggest programmatic improvements.
- Day to day
- function as resource for planning and evaluation of clinical studies Function as resource to others involved in planning, implementation and evaluation of clinical studies.
- Day to day
- communicate and interact positively with peers and other departments Communicate and interact with peers and other departments in a manner that is viewed as having a positive effect on patient services.
- Day to day
- interact effectively and sensitively with patients and families Interact effectively with patients/family members and demonstrate sensitivity in regards to cultural diversity, age specific needs and confidentiality.
- Hours stated
- Days ( M-F, 8a-5p ) - 40 hours a week
- Weekends
- no weekends Weekends: No
- On call
- No call
The workplace
University of Michigan Health-West (formerly Metro Health – University of Michigan Health) is a healthcare system headquartered in Wyoming, Michigan, serving as the premier affiliate of the University of Michigan Health system. With a workforce of 1,001 to 5,000 employees,…
Worth asking
- Can you walk me through base pay range and differentials?
- What should I expect for holiday and rotation?
More questions to askFewer questions
- What orientation, preceptor time, and ongoing unit support are included?
- How are patient load, floating, and staffing support handled day to day?
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Your fit
Original listing
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- Shift: Days
- FTE status: 1
- On-call: No
- Weekends: No
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 to include obtaining trials, screening and consenting of patients, performing patient study-visits, education, data management, and drug/device accountability . Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPS) and study specific protocols.
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. Ability to review detailed data and make prompt judgments based on that data. Ability 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. Ability 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. Coordinate and implement procedures to collect data from patient medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis.
Monitor 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).
Coordinate 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.
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What's around it?
Wyoming, MIFrom Census ACS 2024.
Living costs about 5% below the US average
- Median rent
- $1,196/mo
- Household income
- $73,677/yr, all local households, not nurse pay