Neuroscience Research Coordinator A. GENERAL DESCRIPTION This position will be responsible for planning and coordinating regulatory services and activities associated with the Dignity Health Neurological Institute Research Program. This position acts as a clinical liaison and communications link to physicians, office personnel, nursing staff, allied healthcare professionals and patients and their families. This position is responsible for maintaining quality standards for responsive service and professional documentation, maintaining current and accurate policies, procedures and practices, all in a manner which is consistent with the Mission and Philosophy of the Sisters of Mercy. The position encompasses 5 main areas of competency (1) research expertise, (2) data gathering and analysis, (3) assuring governmental regulatory compliance, (4) clinical practice in field of research, and (5) education. B. REPORTS TO 1. Reporting Relationship This position reports to the Clinical Director, Dignity Health Neurological Institute and is accountable for independently supporting clinical research as assigned. 2. Contacts Internal: Frequent contact with other administrative personnel, department managers, Medical Staff, clinical resources and staff to coordinate interdepartmental activities and ensure the timely exchange of information. External: Infrequent contact with administrative personnel and medical staff from other healthcare facilities or programs and the community. C. POSITION SCOPE 1. Following organizational, Federal and sponsor guidelines; perform regulatory requirements for IRB submission of a research protocol, maintain appropriate regulatory documents for all research staff, develop documentation tools to comply with research guidelines, and assist in management of patients on research protocols. This may include, but is not limited to, one or more of the following: a. Screening and enrolling patients onto a study while ensuring pretreatment and study eligibility requirements are met; b. Administering questionnaires (quality of life, etc); c. Developing consent forms consistent with legal, organization Institutional Review Board (IRB) and Department of Health and Human Services (DHHS) requirements; d. Performing laboratory functions as needed, including processing and shipping of blood and/or serum, pharmacokinetic samples, fresh tissue, standard orders, peripheral smears and other tests as required per protocol; e. Serving as a liaison between physicians and patients regarding treatment, related side effects and social stresses. Assist patients and caregivers with various aspects of their participation in the clinical study and what to expect; f. Ensure adequate supplies of investigational and/or protocol supplied drugs are ordered; g. Act as a liaison with insurance carriers and provide information for medical review; h. Upon protocol activation, assist in preparing standard treatment orders specific to the protocol; 2. Initial preparation of new protocols, including IRB submission, periodic progress reports, and education of hospital staff that will be associated with the study. 3. Abstract data from necessary source documentation to complete flow sheets, case report forms, regulatory binders, and any other documents required by the protocol. 4. Prepare for and assist monitoring teams and/or auditors assigned to each protocol, including evaluating protocol study forms for completeness, accuracy and compliance to the protocol, performing consistency checks, editing for errors and gathering records, reports, radiographs, scans and other necessary materials required for institutional site audits. 5. Report serious adverse events according to study sponsor, cooperative and consortium groups, FDA, NCI and institutional IRB guidelines. 6. Attend investigator/study coordinator meetings for protocol initiation and subsequent monitoring visits as required by study sponsor. 7. Prepare for and participate in quality assurance audits conducted by the study sponsor or other specially designated groups when requested. 8. Participate in and conduct continuing educational activities; attend meetings relevant to neuroscience and clinical trials; attend seminars and conferences related to the field of clinical research; and attend courses related to professional development 9. Provide information and assist investigators with publication review and analysis of data for presentation at meetings or in preparation of manuscripts. 10. Conduct reviews of proposed protocols with emphasis on areas concerning data management and special sample collection and processing. 11. Performs all other duties, as assigned. D. MAJOR CHALLENGES Coordinating and monitoring assigned research activities related to the Dignity Health Neurological Institute. This position is challenging in that it requires sophisticated and statistical thinking, planning, and development in order to support effective research services in a manner that is consistent with the objectives of the Dignity Health Neurological Institute. E. FREEDOM TO ACT This position has the accountability to evaluate and make appropriate recommendations for new study protocols; development and implementation of procedures; and development and maintenance of quality assurance activities. F. PRINICPLE ACCOUNTABILITIES Ensure that all actions taken and methods used to produce the results outlined below incorporate and promote the Mission and Philosophy of the Sisters of Mercy. 1. Maintains and develops all appropriate research documentation and tools to comply with research guidelines, and to assist in management of patients on research protocols. 2. Demonstrates self-motivation and maintains professional competence through participation in appropriate educational programs and other learning experiences. 3. Maintains a good working relationship with senior administration, medical staff, medical directors, and inter- and intradepartmental personnel to facilitate achievement of goals and objectives. Provides ongoing evaluation of departmental goals and objectives 4. Supports the development and introduction of new technologies, services, programs, in cooperation with the Clinical Director to meet the needs of the community in a timely, efficient, and professional manner. 5. Acts as an ambassador in coordinating research relating to the Dignity Health Neurological Institute. G. POSITION REQUIREMENTS 1. Specific Knowledge Demonstrates good leadership, decision-making and judgment skills. Analytical skills to evaluate information, practices and procedures, formulate logical and objective conclusions and make recommendations for effective solutions. Good organization, communication and planning skills. Knowledge of basic anatomy and medical terminology. Good writing skills including ability to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms. Possess mathematical abilities to perform calculations involving basic accounting, body surface area (BSA) calculation and drug dosage calculations. Ability to meet the scope of the program with general supervision and with frequent changes in priorities and deadlines. Working knowledge of Microsoft Word and Excel. Ability to work cooperatively as a team member in a diverse workforce. 2. Specific Requirements Current California RN license. This position requires at least a BSN degree or equivalent in health related field. Minimum of one year experience as a research coordinator or position requiring preparation and conduct of research studies. Experience in clinical area relevant to patient population. Must be able to write effectively for a variety of audiences, both professional and lay. H. WORKING CONDITIONS Physical Factors: physically able to walk, stand, stoop and lift. good manual dexterity. visual and auditory acuity. Detailed physical job analysis on file in Employee Health Services. About Dignity Health Dignity Health, one of the nation"s five largest health care systems, is a 21-state network of nearly 9,000 physicians, 55,000 employees, and more than 380 care centers, including hospitals, urgent and occupational care, imaging centers, home health, and primary care clinics. Headquartered in San Francisco, Dignity Health is dedicated to providing compassionate, high-quality and affordable patient-centered care with special attention to the poor and underserved. In 2013, Dignity Health provided nearly $1.7 billion in charitable care and services. For more information, please visit our website at www.dignityhealth.org. You can also follow us on Twitter and Facebook.