CLINICAL TRIALS NURSE CARE COORDINATOR

Job Summary:

Essential Duties and Responsibilities

• Supports and promotes the mission and values of Covenant Health Ministry.
• Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
• Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
• Manages a panel of patients to ensure continuity of care, patient adherence to study protocols, and identifications of barriers preventing adherence study protocols.
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
• Works with practice managers and clinical managers to initiate workflow and process changes as needed in a constructive and supportive manner.
• Participates in preparation and management of research budgets and monetary disbursements.
• Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. Communicates with laboratories or investigators regarding laboratory findings.
• Reviews scientific literature. participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical studies affairs and issues.
• Orders drugs or devices necessary for study completion.
• Solicits industry-sponsored trials through contacts and professional organizations.
• Renders professional nursing care to patients within and assigned unit of the hospital, in support of medical care as directed by medical staff and pursuant to objectives and policies of the hospital.
• Displays an ability to act as a resource for nursing care areas when acuity and census outweigh resource availability.
• Assists with solution identification in response to problems and conflicts
• Promotes a vision of clinical nursing leadership within the nursing staff members of the unit/department that includes clinical collaborative, research and education components of the clinical trial role.
• Educate the patient and family about the informed consent process and obtains written informed consent according to the federally specified guidelines.
• Performs initial interview and assessment during each patient visit, plans appropriate care under the physician’s direction and in collaboration with the members of the research team.
• Follows protocol and written orders.
• Documents interventions, response to treatment and evaluation in Progress Note and Case Report Forms.
• Evaluates side effects and toxicities at each patient visit and documents adverse events.
• Instructs potential research participants and their family members in aspects of the patients care, treatment, possible side effect and symptom management strategies.
• Contributes to the development of and implements protocol specific patient education materials.
• Incorporates evidenced based practice in patient care according to policy.
• Comply with regulatory requirements as stated through DNV, OPHS, DHHS, and Nurse Practice Act.
• Provides evidence that nurses have access to systems to report safety concerns and errors in a just culture environment
• Meets requirements of outside regulating agencies, including DNV, CMS, ACOS and other agencies as appropriate to the clinical area.
• Practices according to the ANA guidelines of care as adopted by the nursing division and adheres to the Nurse Practice Act of NH.
• Renders professional nursing care to patients as directed by the investigational protocol and physician pursuant to the objectives and policies of the CIRB.
• Develops an environment in which quality care can be delivered through improvement planning and implementation for the area of practice
• Compliant in achieving unit specific competencies and requirements
• Identifies gaps in oncology care within the organization and works to develop plan of care to correct these gaps in collaboration with departmental leadership and shared