Clinical Research Nurse RN

apartment MyMichigan Health location_onMidland, MI, US

Summary

Clinical Research Nursing is the specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity of the research protocol (ANA, 2016). The Clinical Research Nurse is responsible for human subject protection, care coordination and continuity, contribution to clinical science, clinical practice and study management. (IACRN, 2012). MyMichigan Clinical Research Nurses work within a dedicated Research Department as a part of the health system focused primarily on clinical trials in multiple specialty areas. Clinical trials may include pharmaceutical and device trials and other research projects directly related to patient treatment or care. The Clinical Research Nurse works under the guidance and supervision of the Principal Investigator, ensures the integrity and quality of clinical trials are maintained and conducted with federal, state, and local regulations, IRB board approvals, and MyMichigan Health policies and procedures.

Responsibilities

(50%)* - Providing Direct Patient Care to Research Study Participants

Ensure compliance with each study’s protocol by providing through review and documentation at each study visit
Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements
Performs medical tests, including but not limited to, vital signs, lab draws and processing, and electrocardiograms
Administers investigational medication and performs patient assessments during clinic visits to determine presence of side effects; notifies Principal Investigator of findings/issues
Provides patient education and medical information to study participants to ensure understanding of proper medication dosage, administration, and disease treatment
Documents medical data in patient chart to capture protocol requirements

(40%)* As a study coordinator, ensures assigned studies are conducted inaccordance with the Food and Drug Administration (FDA), Office of Research Protections (OHRP ), and Good Clinical Practice (GCP)guidelines

Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
Develops accurate source materials to ensure compliance from all site staff
Provides accurate and timely data collection, documentation, entry, and reporting in both sponsors, Clinical Research leadership, and overseeing IRB, as indicated
Ensures appropriate training and credentialing for assigned protocols and associated staff
Supports the regulatory staff in the maintenance of regulatory documents
Communicates and collaborates specific study requirements to there search team, including internal and external parties, sponsors, monitors, PI, and study participants
Ensures compliance with research protocols through participation in ongoing quality control audits, including maintaining ongoing investigational drug accountability

(10%)* - Complete required professional development and compliance training activities required by MyMichigan Health and as needed for the position.

Maintain Good Clinical Practice, IATA, and other training as required
Complete Annual Compliance Modules for position
Participate as a part of the research team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
Occasional travel to attend sponsor study training meetings
On-call for weekends/evenings - rotated among all study coordinators
based on FTE allocation

Other Duties And Responsibilities

Demonstrate excellent customer service.

Always promotes subject safety.

Contribute to the MyMichigan Health organization targets for patient satisfaction and net operating margin.

Follow ALCOA principles for research documentation.

Establish effective working relationships with participants, families, physicians, physician office staff, hospital staff, pharmaceutical company representatives, and research related visitors.

Acts as liaison between all involved clinical areas and staff of the protocol requirements.

Work collaboratively with investigators, sub investigators, referring physicians, other clinical research nurses, and hospital staff.

Provides education for patients and families regarding the protocol, including the disease process, plan of care, symptom awareness, and the need to report adverse events.

Provide in service education to the clinical staff of the hospitals (pharmacy, nursing, etc.) related to investigational drugs, devices, or procedures, including physiological effects, drug interactions, side effects, nursing care considerations, etc.

Communicate serious adverse events to all appropriate sources.

Accountable to the Manager of Cardiovascular Research.

Represent MyMichigan Health as a professional, high-quality clinical site.

Prepares, coordinates, and participates in on-site monitor visits.

Analyzes protocol and assists in the creation of source documents.

Coordinates activities related to billing, notification of appropriate departments, lab orders, etc.

Understand and contribute to the functional unit plan goals and objectives that align with the organization's strategic plan.

Follow patients and complete post-hospital follow ups, including clinical assessments.

Performs blood draws and basic lab tests as required by the protocol.

Coordinates and provides patient care and follow up to research patients as indicated per protocol and remains available 24 hours daily when on call.

Educate study participants about their rights as research subjects, answer questions, and refer these to the primary investigator.

Ascertain the adequacy of the document and obtain informed consent following the federal regulations before beginning study related procedures.

Provides a copy of signed informed consent to the participant.

Serve as a resource (along with the PI) for questions or concerns of the participant.

Maintain OSHA and Universal Precautions and associated training.

Keep participant's welfare uppermost in mind regarding emergencies, study procedures, termination of the study, etc.

Provides participants with research-related materials.

Reviews and has knowledge of Clinical Research policies and procedures.

Complete and maintain source documents.

Establishes procedures for randomization, blinding, and data collection.

Resolve all sponsor queries regarding participant information.

Per standard operating procedures, document follow up with participants about ongoing adverse events after study completion.

Maintains, closes, and archives study documents according to standard operating procedure.

Certifications and Licensures

ACLS - Advanced Cardiac Life Support

Preferred

BLS - Basic Life Support

Required Equivalent Experience - Within 1 month of hire or transfer

RN - Registered Nurse

Preferred Required

Required Equivalent Experience - BSN is preferred.

Required Education

Education: Associates Degree

Comments: Bachelor's degree in nursing preferred.

Other Information

Experience, Training And Skills

Valid RN license
Two years of recent clinical nursing experience in a hospital, clinic, or similar health care setting
Knowledge of medical terminology, drug calculation skills, clinical medicine, clinical trials, and GCP concepts
Knowledge of federal, state and local regulations, including HIPAA policies and procedures
Detail oriented and meticulous in all aspects of work
Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
Must have a professional demeanor, strong communication skills with patients and physicians and co-workers
Ability to work independently and as a part of a team
Strong interpersonal, customer service, and multi-tasking skills are critical
Must be proficient in Microsoft Office Word and EXCEL, electronic health systems and databases used in the research environment, or have the willingness to learn and demonstrate proficiency
Ability to work well under pressure, multi-task, and manage deadlines

Physical/Mental Requirements And Typical Working Conditions

Exposure to stressful situations, including those involving public contact, as well as, trauma, grief and death.

Able to wear personal protective equipment that includes latex materials or appropriate substitute if required for your position.

Can move freely about facility with or without an assisted device and must be able to perform the functions of the job as outlined in the job description.

Overall vision and hearing are necessary with or without assisted device(s).

Frequently required to sit/stand/walk for long periods of time. May require frequent postural changes such as stooping, kneeling or crouching.

Some exposure to blood borne pathogens and other potentially infectious material. Must follow MyMichigan Health bloodborne pathogen and TB testing as required.

Ability to handle multiple tasks, get along with others, work independently, regular and predictable attendance and ability to stay awake.

Overall dexterity is required including handling, reaching, grasping, fingering and feeling. May require repetition of these movements on a regular to frequent basis.

Physical Demand Level: Medium. Must be able to occasionally (0?33% of the workday) lift or carry 21?50 lbs., frequently 34?66% of the workday 20 lbs. and or Walk/Stand/Push/Pull of Arm/Leg controls and constantly (67?100% or the workday) 10 lbs.

Equivalent Experience And Other Comments (Education)

Other Comments

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Summary Up to 9K sign on bonus for qualified candidates The medical oncology unit will consist of patients with a cancer diagnosis, medical step-down patients, and general medical overflow. This position has basic knowledge of pathophysiology of cancer and is able to assess, plan, implement and evaluate care for patients on this unit. For casual positions: casual employees have no regularly scheduled work hours, but require an understanding of, and agreement to fulfill, the minimum time commitments of the position for as long as the position is held. These are (if needed) at least 48 hours per month with 24 of those hours worked on weekends, and an annual requirement of 24 hours worked on holidays. Responsibilities (30%)* Regularly assesses patient’s/client’s needs and provides skilled nursing services as prescribed by the physician authorized plan of care, and accepted standards of nursing practice. (30%)* Provides direct patient care, including nursing assessment, medication administration, treatments, call lights, assisting with transfers, responding to alarms, etc. (20%)* Evaluates effectiveness of treatment plan and patients' condition to make suggestions and participate in updating/revising the treatment plan in collaboration with other team members, utilizing current information and assessments to improve patient care. (10%)* Processes physician/provider orders and performs physician ordered care accurately, completely and in a timely manner. (10%)* Follows up regarding medication changes and order clarifications. OTHER DUTIES AND RESPONSIBILITIES: Demonstrates the ability to interpret information and reports pertinent data to the physician, including pertinent clinical information. Assess learning needs considering readiness, ability, preferences, and cultural / spiritual variables. Provide education to meet the individual needs and ability to learn. Participates in care conferences as assigned. Develops and maintains good working rapport with interdisciplinary personnel to meet the needs of each resident. Coordinates care provided by patient care technicians. Demonstrates the ability to organize and prioritize the needs of groups of patients or an individual patient. Demonstrates a general ability to manage assignments and perform routine duties on the unit. Instructs other team members when appropriate, explaining goals and rationale for individualized care. Implements clinical and technical aspects of care in accordance with established policies and procedures. Demonstrates understanding of clinical pathways and utilizes appropriately. Remains calm and efficient when working in stressful situations. Documents in an accurate, clear, and concise way and includes pertinent clinical data. Shares information and reports significant changes and/or abnormal findings to appropriate team members. Participates in regulatory surveys. Participates in the performance improvement activities. Assists with orientation and ongoing competencies. Provides a safe and secure environment for patient care. Attend and participate in professional association activities and programs to assure being current on regulations, guidelines, and professional standards. Remains current on new developments by reading professional journals, and attending seminars. Demonstrates understanding of role in emergency preparedness procedures Administers complicated IV therapy, i.e., antibiotic, blood, cardiac drips, and chemotherapy. Assesses patient for signs or symptoms of complications of cancer or treatment protocols. Accurately uses central lines for drawing blood, administering chemotherapy, etc. Interacts positively with patients and families during severe stress situations. Demonstrates critical thinking and integration of theory to practice for medical patients, oncology patients, medical step-down, and telemetry patients. Participates in Transition of Care course for first 12 months after hire or transfer to position. Other duties as assigned. Certifications and Licensures Credential: RN: Registered Nurse Equivalent Experience: Qualification Source: MI Essential: true Credential: BLS: Basic Life Support Equivalent Experience: Within 1 month of hire or transfer Qualification Source: AHA Essential: true Credential: TEAM ADVANCED: Techniques for Effective Aggression Mgt Equivalent Experience: Within 6 months of hire or transfer (Employees who are in this position on or before 8/1/2024 will have 24 months to complete this certification) Qualification Source: Essential: true Required Education Education: ASSOC Equivalent Experience: Associate's degree in Nursing required, Bachelor's degree in Nursing preferred. Education Specialization: NRG Essential: true Education: ASSOC Equivalent Experience: Bachelor's degree in nursing preferred. Education Specialization: Essential: true Other Information EXPERIENCE, TRAINING AND SKILLS: The following education outline is intended for new hires or transfers who are new to Oncology Nursing. Any new hire or transfer who has already received their ONS Chemo / Bio safe handling card and/or their OCN certification is exempt from completing Cancer Basics or Chemotherapy Fundamentals. Chemotherapy Education Pathway: Full time & Part time RN Pass ONS Cancer Basics course within 6 months. Pass ONS Chemotherapy/ Biotherapy Fundamentals of Administration course within 12 months. Obtain ONS Oncology Certified Nurse (OCN) or Certified Medical Surgical nurse (CMSRN) within 3 years. Maintain ONS Chemotherapy/ Biotherapy Fundamentals of Administration or ONS Chemotherapy and Biotherapy Certificate course (if applicable) per ONS recommendations. Additional components of demonstrating competency for all nurses administering antineoplastic agents include: Demonstration of safety and proficiency in the preparation, administration, handling, and disposal of antineoplastic agents as defined in the ONS Chemotherapy/ Biotherapy Fundamentals of Administration course and or the ONS Chemotherapy and Biotherapy Certificate course. Demonstration of compliance with policy for management of chemotherapy spills and extravasation. Demonstration of skill in compliance with the health system's policy for accessing, dressing, and flushing a variety of vascular access devices including Hohn, PICCs, Groshong, Hickman, and implanted medports. Demonstration of skills in the assessment, planning, implementation, and evaluation of the oncology patient and family's learning needs. MyMichigan Health is a technology driven organization and employees need to demonstrate competency in Microsoft® Windows. An employee may be required to participate in further learning opportunities offered by MyMichigan Health. PHYSICAL/MENTAL REQUIREMENTS AND TYPICAL WORKING CONDITIONS: Exposure to stressful situations, including those involving public contact, as well as, trauma, grief and death. Able to wear personal protective equipment that includes latex materials or appropriate substitute if required for your position. Is able to move freely about facility with or without an assisted device and must be able to perform the functions of the job as outlined in the job description. Overall vision and hearing is necessary with or without assisted device(s). Frequently required to sit/stand/walk for long periods of time. May require frequent postural changes such as stooping, kneeling or crouching. Some exposure to blood borne pathogens and other potentially infectious material. Must follow MyMichigan Health bloodborne pathogen and TB testing as required. Ability to handle multiple tasks, get along with others, work independently, regular and predictable attendance and ability to stay awake. Overall dexterity is required including handling, reaching, grasping, fingering and feeling. May require repetition of these movements on a regular to frequent basis. Physical Demand Level: Medium. Must be able to occasionally (0-33% of the workday) lift or carry 21-50 lbs., frequently 34-66% of the workday 20 lbs. and or Walk/Stand/Push/Pull of Arm/Leg controls and constantly (67-100% or the workday) 10 lbs. Equivalent Experience And Other Comments (Education) Education: ASSOC Equivalent Experience: Associate's degree in Nursing required, Bachelor's degree in Nursing preferred. Education Specialization: NRG Essential: true Education: ASSOC Equivalent Experience: Bachelor's degree in nursing preferred. Education Specialization: Essential: true Other Comments #Indeed1HP