Summary:

This position is responsible for coordinating and collaborating with prospective investigators in an effort to facilitate research at CHRISTUS Santa Rosa Health System. This position will market CHRISTUS research services, create and maintain research activity databases, and monitor the impacts of the research studies to include financial and safety risks. 

Responsibilities:

• Facilitates the development of research studies with practitioners interested in performing research at any of the facilities within 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 Santa Rosa Health System.
• Assists researchers and their staff with the preparation of regulatory documentation and CSRHS applications for approval.
• Evaluates proposed clinical research for operational and financial 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 on services and/or procedures.
• Investigates any operational/financial issues that arise from existing studies and provides an evaluation of problem to Leadership for resolution. Presents the resolution to investigators and staff while helping to coordinate implementation.
• 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.
• Assists PIs in interaction with the IRB of record including preparing annual renewals, variances, closeout documentation, and preparing for regulatory audits.
• Collates and summarizes all region-wide research activities.
• Generates and reviews invoices for research services provided by CHRISTUS departments that are remitted to funding body.
• Develops and maintains Standard Operating Procedures for the Regional Research Projects Office that outline the duties and responsibilities of the 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. 

Requirements:

Education

• Requires a Bachelor?s Degree in Healthcare Administration, Research, Business or related field.
• Proficiency in using personal computer databases, spreadsheets and word processing software is required.
• Requires excellent oral and written communication skills.
• Requires excellent organizational skills and knowledge of federal legislation regarding human subject research and the provision of health care is also required.
• Expertise in applying for research protocols is required.
• Some travel to regional hospitals will be required.
• Must be proficient in organizing and examining data.
• Must be able to produce clear and concise products.
• Must be thorough in gathering and reporting information.
•  Must be flexible and be able to relate well with a variety of people. Must be knowledgeable in management applications and be able to expand and apply applicable skills in the work setting.

Experience

• A minimum of three years regulatory experience in clinical research and knowledge of the health care industry is required. 
• Requires experience in creating database and financial analysis.

Licenses, Registrations, or Certifications

• None

Work Schedule:

Varies

Work Type:

Full Time

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About CHRISTUS Health

CHRISTUS HEALTH is an international Catholic, faith-based, not-for-profit health system comprised of almost more than 600 services and facilities, including more than 60 hospitals and long-term care facilities, 350 clinics and outpatient centers, and dozens of other health ministries and ventures. CHRISTUS operates in 6 U.S. states, Colombia, Chile and 6 states in Mexico. To support our health care ministry, CHRISTUS Health employs approximately 45,000 Associates and has more than 15,000 physicians on medical staffs who provide care and support for patients. CHRISTUS Health is listed among the top ten largest Catholic health systems in the United States.

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