Clinical Regulatory Manager

at  Saint Louis University

Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation’s oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.
All About You

JOB SUMMARY:

Under general supervision of the Associate Director – Clinical Trials Office (CTO), the Clinical Regulatory Manager ensures the CTO complies with federal and state regulations pertaining to human subject research as well as internal Saint Louis University policies and procedures. The Clinical Regulatory Manager is responsible for assisting in the IRB review completion and submission. Participates in the monitoring of clinical trials. Ensures compliance with protocol and overall clinical objectives. Knowledge of FDA regulatory requirements is required. May require ACRP or SOCRA Clinical Research Professional exam completion.
Our office provides clinical trial management for industry-sponsored trials, including the oversight of trials and input into their administrative, business, educational, regulatory, and operational functions. The Clinical Trials Office streamlines the processing of research study contracts and budgets with industry partners to facilitate the performance of clinical trials at the Saint Louis University School of Medicine. The office also centralizes important administrative functions and establishes standard policies and procedures for successful management of clinical trials. This ensures the ease of use and proper documentation of all trial procedures. If you are not located in the St. Louis area, we are open to a remote employee in any of the following states: Alabama, Arizona, California, Colorado, Illinois, Indiana, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, North Carolina, Ohio, Oklahoma, Rhode Island, Tennessee, Texas, Utah, Virginia, West Virginia, or Wisconsin with quarterly travel to Saint Louis University.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to communicate effectively to a broad audience with various needs
• Knowledge of industry regulations
• High degree of ethical standards
• Working knowledge of Medicare/Medical billing processes
• Familiarity with Microsoft Office Suite (Excel, PowerPoint, etc.)
• Strong communication and collaborative team building mindset
• Strong working knowledge of Food and Drug Administration, Office for Human Research Protections, and International Council for Harmonization regulatory guidelines
• Excellent planning, time management and organizational skills

MINIMUM QUALIFICATIONS:

• Bachelor’s degree; supplemented with three (3) years of related experience, preferably in the field of clinical research or Associate’s degree; supplemented with five (5) years of related experience, preferably in the field of clinical research or seven (7) years of related experience is required, preferably in the field of clinical research. Minimum three (3) years’ Clinical Trials experience with regulatory background.
  Salary/Benefits:
  $64,960-81,200 DOE plus benefits including vacation and sick leave, health/dental/vision/life insurance, 403B retirement savings plan and match, tuition remission, employee assistance program and wellness program.
  Function
  Clinical Research
  Scheduled Weekly Hours:
  40
  Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. We welcome and encourage applications from minorities, women, protected veterans, and individuals with disabilities (including disabled veterans). If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847

• Responsible for completion and submission of the CTO’s review of new/continuing review protocol applications to the Institutional Review Board (IRB).
• Assists with the development of coverage analyses based upon federal Medicare guidelines.
• Facilitates submission and review of clinical trial contracts and budgets in conjunction with various internal and external offices.
• Serves as the University administrator providing compliance oversight of a national clinical trials registry.
• Contributes to policy and procedure development, review, training, and evaluation.
• Attends training and in-service sessions and performs other duties as assigned.
• Performs other duties as assigned.