Registered Nurse Clinical Research Senior - Research Industry

Develop and maintain recordkeeping systems and procedures. Facilitates the development of research studies with practitioners/ investigators interested in performing research at any of the facilities within the CHRISTUS Santa Rosa Health System. Functions as a liaison between clinical departments, support services, Medical Staff and administration to facilitate multi-disciplinary projects and teams for clinical research.

Provides education, formal and informal, to departments, prospective investigators, Medical Staff and administration on the research process at CHRISTUS Health. Assists and educates researchers and their staff with the preparation of regulatory documentation and CHRISTUS Health applications for approval at both internal and external IRBs. Assists PIs in interaction with the IRB of record including submission, preparation of annual renewals, variances, closeout documentation, and preparation for regulatory audits.

Evaluates proposed clinical research for operational impact on CSRHS, including adherence to the Ethical and Religious Directives for Catholic Healthcare, Catholic Social Teaching and the Mission, Vision and Values of Christus Health. Coordinates the information sharing of potential studies to all stakeholders that may be impacted in an effort to develop a reasonable plan of implementation. Creates monthly executive summaries of prospective and current studies for review by Leadership.

Investigates and evaluates the financial impact of prospective studies, and any operational/financial issues that arise from existing studies. Monitors on-going clinical research for adherence to regulatory guidelines and determinations. Assists in the measurement and assessment of data from the Adverse Event Reports, including providing follow-up and feedback to staff, tracking and trending and preparing summary reports for Medical Staff and departments.

Interacts with industry sponsors and PI research operations staff for industry-sponsored studies and management of sponsored research. Provides Clinical Research Coordinator role at CHRISTUS Santa Rosa hospitals. Collates and summarizes all market-wide research activities.

Reviews invoices for research services provided by CHRISTUS departments that are remitted to funding body. Screens patients for protocol eligibility and participation in clinical trials. Participates in the coordination and monitoring of patient treatment and dispensing of study medication.

Monitors and evaluates patient response to protocol treatment in collaboration with the physician. Provides education regarding study activities to patient, relatives and CHRISTUS Santa Rosa staff as necessary per protocol. Collect and/or process human specimens per protocol including blood, urine, sputum, buccal swabs, etc. Performs other professional nursing duties, including administration of medications, as required by protocol.

Prepares regulatory documents for Institutional Review Board and/or sponsor. Develops and maintains Policies and Standard Operating Procedures for the Regional Clinical Research that outline the duties and responsibilities of the Regional Clinical Research Office and how those functions are carried out. Demonstrates competence to perform assigned responsibilities in a manner that meets the age-specific and developmental needs of members served by the Department.

Appropriately adapts assigned assessment, treatment, and/or care methods to accommodate the unique physical, psychosocial, cultural, age-specific and other developmental needs of each member served. Takes personal responsibility to ensure compliance with all policies, procedures and standards as promulgated by state and federal agencies, the hospital, and other regulatory entities. Performs all duties in a manner that protects the confidentiality of patients and does not solicit or disclose any confidential information unless it is necessary in the performance of assigned job duties.

Performs other duties as assigned.