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GENERAL SUMMARY:   Under direction, provides professional nursing care for and enrolls/monitors adult patients in Clinical Research studies following Iowa Heart Center’s (IHC) established standards and practices.    ESSENTIAL FUNCTIONS: - Organizes research protocol to include, but not limited to, obtaining consents. - Assists in preparation of information for submission to Institutional Review Board (IRB) for approval and completes correspondence between IRB and drug companies. - Serves as Iowa Heart Center’s resource and liaison in all aspects of each protocol to study with patients, families, hospitals, office staff, physicians, pharmaceutical companies and coworkers. - Completes all necessary paperwork connected to research study. - Coordinates all activities related to patients’ diagnostic testing, visits and evaluations. - Organizes and assists with site visits with drug companies and monitors CRA. - Organizes and participates in meetings as required for orientation to study, update or review, etc. - Provides backup and maintains an understanding of all other protocols which the group is involved in for support and relief of primary nurse on projects. - Conducts in-service education where needed. - Conducts patient phone calls or follow-up assessments as needed. - Participates in professional development activities and maintains professional affiliation and certification. - Maintains statistical collection of all protocols. - Administration of research protocols by finding patients who meet inclusion/exclusion criteria, scheduling in office doctor and lab visits. Coordinate and/or perform other tests in and outside the clinic. Maintain accurate documents, FDA records and case form records, complete health and drug histories and disease assessments. Review patient data for safety and administration purposes. Make corrections and clarifications of data for sponsor monitors. - Assess learning needs of patient and significant others. Teach patients about medications and procedures of protocol. Gives accurate and complete information Obtains patient consent signatures after instruction completed. - Writes patient consent forms to meet HIPAA, FDA, INH and IRB requirements. - Follow guidelines for human subjects - Travels to Iowa Heart offices as needed - Certified in handling, packing, and transportation of hazardous materials, (ie.blood)
Job ID
2020-114409
Department
Cardio Research
Facility
MercyOne Des Moines Medical Center
Shift
Day
Employment Type
Full Time
Location
IA-WEST DES MOINES
Coordinates the full scope of patient care and data management for investigational drug studies.    This includes patient evaluation and enrollment, direct and indirect patient management, data collection and long term follow up. Working Relationships:    The Research Center Coordinator is responsible to the Research Center Manager.  The Research Coordinator is in daily contact with patients, visitors, physicians, and other professional employees.  The Research Coordinator has contact with persons outside the hospital. Adequate conversational English is required in order that the individual be able to take direction from management, understand how to complete job tasks, communicate adequately with patients and co-workers as necessary, understand and follow safety guidelines, and understand the Associate Handbook and all hospital policies.    - Determines patient eligibility for participation in drug and/or medical device research studies/protocols, ensuring the rights, safety and welfare of patients at all times. - Analyzes established protocol(s) guidelines to understand, interpret and implement provisions, assessments and requirements and to ensure that proper protocol procedures and medication administration are followed and executed accordingly - Works collaboratively with study sponsors (drug companies), and prepares/provides accurate, timely and complete documentation. - Serves as point-person for routine monitoring visits and external audits of assigned studies as conducted by sponsors, the FDA and/or other entities. - Participates in department operations to include coordinating protocol-specific meetings, communications and needed services for other FHS departments. - Cultural Sensitivity and Competence:  Demonstrates proper use of communication tools/materials for effective communication and understands how the culture(s) of patient populations can affect communication, collaboration and the provision of care, treatment and services.  Patient Population Served:  Demonstrates knowledge and proper skills associated with the department’s defined specific populations served. - Performs related duties as required.
Job ID
2020-119164
Department
Research Department
Facility
CHI Saint Joseph East
Shift
Day
Employment Type
Full Time
Location
KY-LEXINGTON

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