What are the responsibilities and job description for the Nurse - Clinical Trials Office position at Baton Rouge General?
Description
JOB PURPOSE OR MISSION: Implements basic clinical protocol management via study requirements; proficiently performs the nursing process, including assessment, planning, implementation and evaluation; safeguards the rights and well being of the study participant; and provides general operational support and administrative duties related to clinical activities for research study. Performs job for the age population served, as defined in the department's scope of service.
PERFORMANCE CRITERIA
CRITERIA A: Everyday Excellence Values - Employee demonstrates Everyday Excellence values in the day-to-day performance of their job.
PERFORMANCE STANDARDS:
• Demonstrates courtesy and caring to each other, patients and their families, physicians, and the community.
• Takes initiative in living our Everyday Excellence values and vital signs.
• Takes initiative in identifying customer needs before the customer asks.
• Participates in teamwork willingly and with enthusiasm.
• Demonstrates respect for the dignity and privacy needs of customers through personal action and attention to the environment of care.
• Keeps customers informed, answers customer questions and anticipates information needs of customers.
CRITERIA B: Corporate Compliance - Employee demonstrates commitment to the Code of Conduct, Conflict of Interest Guidelines, and the GHS Corporate Compliance Guidelines.
PERFORMANCE STANDARDS:
• Practices diligence in fulfilling the regulatory and legal requirements of the position and department.
• Maintains accurate and reliable patient/organizational records.
• Maintains professional relationships with appropriate officials; communicates honesty and completely; behaves in a fair and nondiscriminatory manner in all professional contacts.
CRITERIA C: Personal Achievement - Employee demonstrates initiative in achieving work goals and meeting personal objectives.
PERFORMANCE STANDARDS:
• Uses accepted procedures and practices to complete assignments. Uses creative and proactive solutions to achieve objectives even when workload and demands are high.
• Adheres to high moral principles of honesty, loyalty, sincerity, and fairness.
• Upholds the ethical standards of the organization.
CRITERIA D: Performance Improvement - Employee actively participates in Performance Improvement activities and incorporates quality improvement standards in his/her job performance.
PERFORMANCE STANDARDS:
• Optimizes talents, skills, and abilities in achieving excellence in meeting and exceeding customer expectations.
Initiates or redesigns to continuously improve work processes.
• Contributes ideas and suggestions to improve approaches to work processes.
• Willingly participates in organization and/or department quality initiatives.
CRITERIA E: Cost Management - Employee demonstrates effective cost management practices.
PERFORMANCE STANDARDS:
• Effectively manages time and resources
• Makes conscious effort to effectively utilize the resources of the organization - material, human, and financial.
• Consistently looks for and uses resource saving processes.
CRITERIA F: Patient & Employee Safety - Employee actively participates in and demonstrates effective patient and employee safety practices.
PERFORMANCE STANDARDS:
• Employee effectively communicates, demonstrates, coordinates and emphasizes patient and employee safety.
• Employee proactively reports errors, potential errors, injuries or potential injuries.
• Employee demonstrates departmental specific patient and employee safety standards at all times.
• Employee demonstrates the use of proper safety techniques, equipment and devices and follows safety policies, procedures and plans.
JOB FUNCTIONS
ESSENTIAL JOB FUNCTIONS include, but are not limited to:
1. Participates in the planning, development, and implementation of clinical protocols in accordance with department standards.
PERFORMANCE STANDARDS:
• Participates in protocol feasibility assessment.
• Establishes appropriate data collection systems and procedures, according to pre-established research protocol.
• Educates hospital staff on protocol-specific interventions.
• Screens patients for protocol eligibility, reviews test results.
• Educates eligible patients and participate in the informed consent process.
• Enrolls eligible patients in research protocols.
• Coordinates protocol-specific appointments, tests, treatments and visits
• Coordinates and monitors the collection, processing and recording of clinical data as required by established study protocol.
• Communicates study data, protocol deviations, on-site adverse events and study results to department manager.
• Maintains complete source documentation and oversees the preparation of study activity reports for sponsors and various medical, legal and regulatory bodies, as appropriate.
• Ensures that all clinical activities are carried out in accordance with established research protocol.
2. Assumes oversight of regulatory requirements for clinical research protocols.
PERFORMANCE STANDARDS:
• Ensures that regulatory documents are submitted to sponsors and Institutional Review Boards as required.
• Ensures that BRG Institutional Review Board and Institutional Research Oversight Committee policies and guidelines are followed in the conduct of clinical research protocols.
3. Facilitates problem solving in the Research Department.
PERFORMANCE STANDARDS:
• Utilizes critical thinking skills in determining appropriate actions in a variety of situations.
• Demonstrates the ability to process through to solution for a variety of problems.
• Represents and promotes the objectives and activities of research studies to various internal/or external constituencies, as appropriate.
5. Performs other duties as assigned.
EXPERIENCE REQUIREMENTS
3 years experience in clinical trials.
SPECIAL SKILL, LICENSE AND KNOWLEDGE REQUIREMENTS
Louisiana Nursing License
Skill in the use of personal computers and related software applications.
Strong knowledge of the principles and procedures of clinical research.
Organizing and coordinating skills.
HIPAA REQUIREMENTS:
Maintains knowledge of and adherence to all applicable HIPAA regulations appropriate to Job Position including but not limited to: Medical records w/o limitation both paper and electronic, patient demographics, lab and radiology results, patient information related to surgery or appointment schedules, medical records related to quality data, patient financial information, patient related complaints, information related to patient location, religious beliefs and research information.
SAFETY REQUIREMENTS:
Maintains knowledge of and adherence to all applicable safety practices appropriate to Job Position including but not limited to: Incident reporting, handling of wastes, sharps and linen, PPE, exposure control plans, hand washing, environment of care, patient identification, administers medication and blood products, validates, transports, monitors or observes patients for procedures including infusion pumps, monitors clinical alarms, collect blood samples, radiation safety, and chemotherapy precautions.
JOB PURPOSE OR MISSION: Implements basic clinical protocol management via study requirements; proficiently performs the nursing process, including assessment, planning, implementation and evaluation; safeguards the rights and well being of the study participant; and provides general operational support and administrative duties related to clinical activities for research study. Performs job for the age population served, as defined in the department's scope of service.
PERFORMANCE CRITERIA
CRITERIA A: Everyday Excellence Values - Employee demonstrates Everyday Excellence values in the day-to-day performance of their job.
PERFORMANCE STANDARDS:
• Demonstrates courtesy and caring to each other, patients and their families, physicians, and the community.
• Takes initiative in living our Everyday Excellence values and vital signs.
• Takes initiative in identifying customer needs before the customer asks.
• Participates in teamwork willingly and with enthusiasm.
• Demonstrates respect for the dignity and privacy needs of customers through personal action and attention to the environment of care.
• Keeps customers informed, answers customer questions and anticipates information needs of customers.
CRITERIA B: Corporate Compliance - Employee demonstrates commitment to the Code of Conduct, Conflict of Interest Guidelines, and the GHS Corporate Compliance Guidelines.
PERFORMANCE STANDARDS:
• Practices diligence in fulfilling the regulatory and legal requirements of the position and department.
• Maintains accurate and reliable patient/organizational records.
• Maintains professional relationships with appropriate officials; communicates honesty and completely; behaves in a fair and nondiscriminatory manner in all professional contacts.
CRITERIA C: Personal Achievement - Employee demonstrates initiative in achieving work goals and meeting personal objectives.
PERFORMANCE STANDARDS:
• Uses accepted procedures and practices to complete assignments. Uses creative and proactive solutions to achieve objectives even when workload and demands are high.
• Adheres to high moral principles of honesty, loyalty, sincerity, and fairness.
• Upholds the ethical standards of the organization.
CRITERIA D: Performance Improvement - Employee actively participates in Performance Improvement activities and incorporates quality improvement standards in his/her job performance.
PERFORMANCE STANDARDS:
• Optimizes talents, skills, and abilities in achieving excellence in meeting and exceeding customer expectations.
Initiates or redesigns to continuously improve work processes.
• Contributes ideas and suggestions to improve approaches to work processes.
• Willingly participates in organization and/or department quality initiatives.
CRITERIA E: Cost Management - Employee demonstrates effective cost management practices.
PERFORMANCE STANDARDS:
• Effectively manages time and resources
• Makes conscious effort to effectively utilize the resources of the organization - material, human, and financial.
• Consistently looks for and uses resource saving processes.
CRITERIA F: Patient & Employee Safety - Employee actively participates in and demonstrates effective patient and employee safety practices.
PERFORMANCE STANDARDS:
• Employee effectively communicates, demonstrates, coordinates and emphasizes patient and employee safety.
• Employee proactively reports errors, potential errors, injuries or potential injuries.
• Employee demonstrates departmental specific patient and employee safety standards at all times.
• Employee demonstrates the use of proper safety techniques, equipment and devices and follows safety policies, procedures and plans.
JOB FUNCTIONS
ESSENTIAL JOB FUNCTIONS include, but are not limited to:
1. Participates in the planning, development, and implementation of clinical protocols in accordance with department standards.
PERFORMANCE STANDARDS:
• Participates in protocol feasibility assessment.
• Establishes appropriate data collection systems and procedures, according to pre-established research protocol.
• Educates hospital staff on protocol-specific interventions.
• Screens patients for protocol eligibility, reviews test results.
• Educates eligible patients and participate in the informed consent process.
• Enrolls eligible patients in research protocols.
• Coordinates protocol-specific appointments, tests, treatments and visits
• Coordinates and monitors the collection, processing and recording of clinical data as required by established study protocol.
• Communicates study data, protocol deviations, on-site adverse events and study results to department manager.
• Maintains complete source documentation and oversees the preparation of study activity reports for sponsors and various medical, legal and regulatory bodies, as appropriate.
• Ensures that all clinical activities are carried out in accordance with established research protocol.
2. Assumes oversight of regulatory requirements for clinical research protocols.
PERFORMANCE STANDARDS:
• Ensures that regulatory documents are submitted to sponsors and Institutional Review Boards as required.
• Ensures that BRG Institutional Review Board and Institutional Research Oversight Committee policies and guidelines are followed in the conduct of clinical research protocols.
3. Facilitates problem solving in the Research Department.
PERFORMANCE STANDARDS:
• Utilizes critical thinking skills in determining appropriate actions in a variety of situations.
• Demonstrates the ability to process through to solution for a variety of problems.
• Represents and promotes the objectives and activities of research studies to various internal/or external constituencies, as appropriate.
5. Performs other duties as assigned.
EXPERIENCE REQUIREMENTS
3 years experience in clinical trials.
SPECIAL SKILL, LICENSE AND KNOWLEDGE REQUIREMENTS
Louisiana Nursing License
Skill in the use of personal computers and related software applications.
Strong knowledge of the principles and procedures of clinical research.
Organizing and coordinating skills.
HIPAA REQUIREMENTS:
Maintains knowledge of and adherence to all applicable HIPAA regulations appropriate to Job Position including but not limited to: Medical records w/o limitation both paper and electronic, patient demographics, lab and radiology results, patient information related to surgery or appointment schedules, medical records related to quality data, patient financial information, patient related complaints, information related to patient location, religious beliefs and research information.
SAFETY REQUIREMENTS:
Maintains knowledge of and adherence to all applicable safety practices appropriate to Job Position including but not limited to: Incident reporting, handling of wastes, sharps and linen, PPE, exposure control plans, hand washing, environment of care, patient identification, administers medication and blood products, validates, transports, monitors or observes patients for procedures including infusion pumps, monitors clinical alarms, collect blood samples, radiation safety, and chemotherapy precautions.