Clinical Research RN

University of Michigan Health-West (Formally Metro Health) is looking for Clinical Research RN – Clinical Research.

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:

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

Essential Functions and Responsibilities:

1. 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.
2. Perform protocol-required clinical assessments and procedures within State of Michigan Registered Nurse scope of practice and per delegation of the principal investigator..
3. 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.
4. 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.
5. 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.
6. 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.
7. Function as resource to others involved in planning, implementation and evaluation of clinical studies. Assist in training new personnel.
8. 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.