Clinical Research Associate II - RN

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Provide coordination, collaboration, and consultation with physicians, health team members, patients and families, and various other medical professionals regarding research-related activities to assure that protocol specifications are appropriately carried out and communicated. The registered nurse is responsible for the organization and implementation of the nursing process within Sanford Health System and the continuum of care. The nursing process is utilized to assess, diagnose, establish a plan with outcome criteria, intervene, evaluate, and document human responses to actual or potential health problems. This practice includes dependent, interdependent and independent functions. Reports to Clinical Research Manager Education, Experience and Skills Requirements Graduate from American Association of Colleges of nursing or National League for Nursing accredited college of nursing. Current South Dakota and/or North Dakota RN license required or multi-state licensure privileges. Must have three years of clinical experience. Must have an enthusiasm for learning that is carried out in partnership with the clinic and/or hospital staff and other personnel engaged in the research process. Previous training and/or experience in quality management principles and computer skills including database/spreadsheet software preferred. Licensure/Certification Requirement Requires current licensure as a Registered Nurse in the state(s) of practice. Job Specific Competencies
Assessment: Evaluates patient condition in response to study intervention, and the need for further physician assessment as applicable. Collaborates with the investigator and sponsor regarding enrollment goals, sponsor expectation and study procedures. Reviews study protocols and materials and follow-up procedures with potential study subjects. Collects and prepares case report forms and documents for sponsors and or audit review. Assesses subject compliance with the test article and follow-up visits.
Trial Support: Attends and participates in investigator meetings. Monitors enrollment goals and modifies recruitment plan as necessary. Maintains patient screening/enrollment and assures all screening, eligibility and enrollment procedures are followed. Conducts interviews to assess the subject's ability and willingness to follow and complete study procedures and visits. Maintains study documentation of each study and ensures all documentation is accurate. Meets with monitor/auditors during visits to discuss case report form completion, query resolution and other protocol-related issues.
Customer Service: Communicates effectively with subjects, research teams, IRB and sponsor and sponsor's delegated representatives by reviewing the protocol requirements. Responds to patient's concerns and questions in a professional manner. Makes a decision considering the impact on all other areas.
Compliance: Assists with the preparation and submission of institutional review board documents. Ensure all documents are obtained and completed as required by protocol. Submits protocol amendments and progress reports to IRB in required timeframes. Provides timely notification of Serious Adverse Events to the Sponsor (or delegated representative) and IRB.
Communication: Provides subjects with information about how to report study-related events to the research team. Documents all communications on the study chart. Recognizes and reports common laboratory values and alerts to investigator and sponsor. Initiates collaboration with others outside of the organization.
Leadership: Demonstrates both knowledge and application of research policies, procedures and guidelines.
Core Competencies Customer Service
Interacts with customers in a warm and friendly way.
Takes immediate action to meet customer requests or needs.
Listens to understand what customers have to say. Safety
Recognizes safety hazards and takes corrective action; seeking assistance when needed.
Demonstrates knowledge of operational policies and procedures.
Performs work safely, without causing harm or risk to self, others or property. System Behavior
Makes a decision considering the impact of the decision on other areas.
Initiates collaboration with others outside of service area.
Demonstrates personal commitment to the principles, values, and ethics of the organization.
Models accountability for learning by sharing knowledge and learning from others. Interpersonal/Communication/Relationships
Builds effective working relationships.
Expresses appreciation to others for their work.
Treats others with respect. Leadership Competencies
Demonstrates both knowledge and application of Sanford policies, procedures, and guidelines.
Demonstrates the ability to take charge, take unpopular stands if necessary, face difficult situations, and is looked to for direction from others.
Facilitates and supports change within the Sanford Health.
Demonstrates commitment to continuous learning for themselves and staff.
Demonstrates and applies continuous quality improvement knowledge and skills. Information Management Competencies
Demonstrates skill in accessing, preparing and using information as relevant to position.
Verbalizes and demonstrates knowledge of procedures for maintaining security, confidentiality and integrity of employee, patient, family and other medical information.
Demonstrates ability to collect, analyze and present data as appropriate to position. Equipment Competencies
Demonstrates skill in use of equipment relevant to position; verbalizes knowledge of appropriate safety procedures.
Diagnoses equipment problems; fixes or seeks out someone to fix.
Consistently informs appropriate person of problems encountered with repairs or calibration of equipment. Professional/Clinical Practice Competencies
Assessment: Collects health data from patient/family.
Planning: Develops a plan of care in collaboration with patient, family, and other health care providers.
Implementation: Implements the services/needs as identified in the plan of care.
Evaluation: Evaluates the patient's progress toward the attainment of outcomes.
Documentation: Gathers, documents, and transmits important patient information throughout the system. Age Related Competencies
Applies knowledge of growth and development in customer interactions and adapts care according to patient's age/developmental stage. Blood Exposure
This position is classified as a Category II position under OSHA guidelines with low risk of exposure to bloodborne pathogens and other potentially infectious materials. Supervisory Dimension Physical Requirements: View Physical Requirements