Experience Inc. Jobs

St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care.

The Human Research Protections Coordinator supports all human subject research protection activities conducted under the auspices of the Human Research Protections Office to ensure the rights and welfare of participants in research studies are protected and that St. Luke's is in compliance with institutional, state and local, and federal regulations.

JOB DUTIES AND RESPONSIBILITIES:

• Demonstrate clear high-level knowledge and practice of ICH/GCP guidelines, FDA regulations, OHRP regulations, HIPPA Regulations and Confidentiality Policy, and IRB policies related to human subject protection and clinical research in general.

• Coordinate HRPO and IRB functions including but not limited to maintenance and updating of Policies and Procedures, workflow efficiency and process improvements, record-keeping and other administrative processes, education for researchers, application of human subjects regulations, and coordination of IRB meetings and outcomes of review.

• Track IRB submissions, approvals and expiration dates for all protocols with accuracy, including initial, annual and amendment submissions within to ensure timely turnaround times.

• Ensure efficiency and rapid response to ensure timely turnaround of all IRB processes. Attend Pre-IRB and IRB meetings, and coordinate preparatory activities as well as post-meeting activities.

• Serve as a triage point for all IRB submissions, ensuring that submissions are accurate, properly formatted, complete, and in compliance with regulations and IRB policies and procedures, and appropriately assign level of review required, as well as reviewers.

• Serve as primary resource to the SLUHN research community and research-related offices concerning interpretation and application of federal, state, and local human subject regulations, IRB policy and procedures, preparation and submission of IRB applications, reporting of adverse events, informed consent procedures, privacy issues, protocol violations, overall IRB issues, etc.

• Assist in the development and implementation of an internal quality assurance program with necessary reporting mechanisms and action plans for non-compliance, including monitoring QA audits and reviewing QA audit reports.

• Coordinate non-compliance and research misconduct reporting processes, create documentation and correspondence as necessary, and communicate findings of non-compliance/misconduct to institutional officials and federal authorities as appropriate.

  PHYSICAL AND SENSORY REQUIREMENTS:

  Requires sitting for up to seven hours per day, 4 hours at a time. Standing for up to 4 hour per day, 3 hours at a time. Requires occasional fingering, handling and twisting and turning. Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 20 pounds. At times requires reaching above shoulder level. Must have the ability to hear as it relates to normal conversation, seeing as it relates to general vision.

  EDUCATION:

  Bachelor’s degree preferred with a minimum of 2 years directly related experience required. Must have high-level working knowledge of medical and research terminology, and research regulations as they relate to Human Research Protections.

  TRAINING AND EXPERIENCE:

  Required: Knowledge of Microsoft Office Programs: Word, Excel, PowerPoint, Outlook; Internet Functions, e-IRB systems. Must 2 years of directly related experience.

Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!!

St. Luke's University Health Network is an Equal Opportunity Employer. (http://www.slhn.org/EOE)