Description
POSITION OBJECTIVE
Working under limited supervision, coordinate, implement and evaluate clinical research trials, studies or projects. The nurse will be a member of a multidisciplinary research and development team designing and investigating new Class III medical devices for neuromodulation with a focus on restoring motor and sensory function to people with disabilities. The nurse will serve as the primary contact for research participants and will document, observe, and deliver care to subjects enrolled in research studies in accordance with study protocols. The nurse will provide nursing care to research participants, follow research protocols, uphold high standards of care and strict adherence to human subjects protection policies, and monitor patients for adverse events. The nurse will evaluate and document participants¿ health and medical information, answer medical questions from the participants and research team, counsel patients in research procedures, and will work with other medical professionals to ensure participant safety and health during device trials. The nurse will schedule and coordinate participant appointments, recruit participants, evaluate patient records for eligibility and follow-up, and perform other administrative duties required for the effective conduct of clinical trials.
ESSENTIAL FUNCTIONS
Coordinate, implement and evaluate clinical research trials, studies, or projects. Provide direct nursing care to research participants. Evaluate and document participants¿ medical status throughout research studies, including documentation in relevant electronic medical records systems. Evaluate participants¿ medical histories and patient records and collect medical assessments to determine eligibility. Coordinate and manage tasks related to surgical procedures for investigational device implantation and explanation, including scheduling operating rooms, interfacing with clinical personnel at Cleveland-area medical institutions, and coordinating clinical tests and assessments required for study protocols. (25%)
Serve as the primary liaison for research participants. Provide timely answers to participant inquiries and medical questions, in consultation with subject matter experts. Schedule participant appointments and coordinate appointments with the research team. Perform subject recruitment activities. Perform administrative duties to enable participant travel to the study site for research visits. Develop education materials for study devices and procedures for study candidates, participants, and their families. Conduct participant and family education to ensure adherence to study protocols. (20%)
Coordinate with the research team, clinical collaborators, and care providers to ensure participant health and safety during clinical trials. Collect medical information from participants, document medical information, and communicate information to relevant team members, including clinician collaborators and regulatory agencies. Monitor participants for adverse events. Assist with preparation of documentation to institutions, medical monitoring committees, and regulatory bodies to report adverse events. (15%)
Assist in developing data collections systems and collecting, analyzing, and managing study data. Assist with the development of publications, grants, presentations, recruitment materials, and reports. (13%)
Provide direction in the development of research protocols and standard operating procedures. Create protocols and standard operating procedures (SOPs) for clinical and administrative tasks. Provide training to students and other team members on protocols and procedures. Assist with overseeing team compliance to relevant human subjects regulations, ethical guidelines, and institutional policies. (10%)
May oversee financial accounts to ensure operations remain within budget. Coordinate with grant administrators at CWRU and medical institution partners to oversee financial accounts, purchase requests, and invoices. Coordinate with institution departments to purchase study supplies and develop and fulfill contracts. (7%)
NONESSENTIAL FUNCTIONS
Assist with IRB, IDE, and other regulatory submissions and maintenance of regulatory approvals. Assist with coordinating administrative tasks for performing clinical trials at CWRU and Cleveland-area medical institutions, such as coordinating team research credentialing, human subjects training, etc. (5%)
Perform other duties as assigned. (5%)
CONTACTS
Department: Daily contact with research team and department staff to coordinate participant visits, maintain workflow, purchase supplies, manage travel, and discuss regulatory issues. (49%)
University: Occasional contact with department administrators regarding workflow, purchasing, and acquiring and providing information necessary for the research. (10%)
External: Regular contact with study participants to schedule research visits, evaluate medical information, and monitor adverse events. Regular contact with study sponsors and regulatory staff to exchange information. (35%)
Students: Occasional contact with graduate students and postdoctoral scholars conducting research on study protocols to coordinate subject visits and ensure protocol compliance. (6%)
SUPERVISORY RESPONSIBILITY
Provide direction and may supervise Research Nurse 1 or other support staff.
QUALIFICATIONS
Education/Experience/Licensure: Bachelor's degree and 3 years of experience or Associate's degree and 7 years of experience or High School education and 11 years of experience required. RN license in the state of Ohio required.
REQUIRED SKILLS
Knowledge and understanding of commonly used concepts, practices, and procedures within the field of nursing and clinical trials.
Ability to perform data review, Electronic Medical Record abstraction, and maintain records in format required by principal investigator.
Knowledge and understanding of research techniques and regulatory requirements. Prior research experience preferred.
Excellent oral and written communication skills and interpersonal skills; must demonstrate the ability to effectively and professionally communicate and work with various individuals from a broad spectrum of disciplines, technical and educational backgrounds within the department, school and university, and with individuals outside the university, including research participants and research candidates and their families.
Strong organizational skills; ability to multi-task, prioritize and meet deadlines. Must demonstrate attention to detail and accuracy, time management skills, and follow through.
Ability to work effectively independently and collaboratively within a team.
Ability to work with sensitive information and maintain confidentiality.
Ability to maintain familiarity and demonstrate knowledge of project priorities, leadership and programs.
Effective problem-solving skills; must demonstrate sound judgment and good decision making.
Must demonstrate flexibility and ability to work under pressure; must be able and willing to work in a fast paced, changing environment.
Ability to operate laboratory equipment.
Proficiency in Microsoft Office (ex: Word) and database management.
Demonstrated willingness to learn new techniques, procedures, processes, and computer programs as needed.
Demonstrated history of successful support, education, and advocacy for all students, aligned with the values, mission, and messaging of the university, while adhering to the staff policy on conflict of commitment and interest.
Ability to meet consistent attendance.
Ability to interact with colleagues, supervisors and customers face to face.
WORKING CONDITIONS
The employee will work indoors in a hospital setting and within the Human Fusions Institute at Case Western Reserve University. Frequent travel to Cleveland area medical institutions, including the Cleveland VA Medical Center, University Hospitals, and MetroHealth Medical Center, is required. The candidate will need to provide their own transportation to facilities at partner institutions in the Cleveland area and will be required to acquire research and/or clinical credentials at partner institutions to complete study activities at these sites. At these clinical locations, the Nurse Coordinator will work as a team with other clinicians, staff, and research subjects. The candidate will assist with scheduling and coordinating clinical tasks at partner institutions, and will follow research protocols in operating rooms at these institutions related to the research projects. The employee may be exposed to bloodborne pathogens. The employee will utilize paper and electronic records and perform repetitive motions using computer mouse and keyboard to type.
Requirements
QUALIFICATIONS
Education/Experience/Licensure: Bachelor's degree and 3 years of experience or Associate's degree and 7 years of experience or High School education and 11 years of experience required. RN license in the state of Ohio required.
