Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: Pediatrics-Res Adm
Work Type: Full Time (Total FTE between 0. 9 and 1. 0)
Shift: Shift 1
Work Schedule: 8 Hr (8:00:00 AM - 4:30:00 PM)
Rush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).
Pay Range: $55.16 - $80.05 per hour
Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush’s anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.
Summary:
The Clinical Research Regulatory Compliance Manager serves as the subject matter expert for a team of Clinical Research Regulatory coordinators within the department of Pediatrics, and liaisons with the Principal Investigators (PIs), Industry Sponsors, the Rush Institutional Review Board (IRB), Corporate Compliance and the Research and Clinical Trials Office (RCTA). Serving as a mentor and providing support and training to ensure that the research team remains up-to-date on the latest clinical research regulations and workflows at the site, state, and federal levels. He/she is responsible for identifying and finding solutions for regulatory and compliance issues within the research area of pediatrics; developing and implementing quality improvement initiatives as it pertains to sponsor industry/pharmaceutical protocols and FDA guidelines; and maintaining collaboration with the Director of Finance and the Research Manager to assist with other functions as needed. The individual who holds this position exemplifies the Rush mission, vision and values and acts in accordance with Rush University Medical Center (Rush) policies and procedures.
Required Job Qualifications:
· Bachelor’s degree required.
· At least 2 years of supervisory and regulatory experience required.
· At least seven years of experience in the academic or pharmaceutical clinical research environment required.
· Relevant certification as a Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP).
· Ability to multitask and manage several projects in parallel, paying attention to detail.
· Strong knowledge of the Code of Federal Regulations pertaining to Human Subject Protections, including 45CFR46, 21CFR50, and 56, Good Clinical Practice, the Declaration of Helsinki, the Belmont Report, and HIPAA required.
· Demonstrated expertise in clinical research methodologies, regulations, and guidelines.
· Must be able to direct a team effectively while also working independently with minimal supervision, with excellent written and oral communication skills.
· Proficient using the Microsoft Office suite and other computer programs.
Preferred Job Qualifications:
· Master’s degree preferred.
Responsibilities:
· Manages and develops a team of regulatory coordinators, but not limited to supervisor of the research team, clinical research coordinators, research nurses, and lab staff.
· Leads regular, timely meetings to track progress of study regulatory activities, including study start-up, maintenance, close-out activities; and provides direct feedback to team members (regulatory documentation completion; IRB (local and central) submission preparation and requirements).
o Manage the daily operations of clinical research studies by coordinating various essential activities. This includes the meticulous design of study protocols, ensuring they adhere to regulatory standards and scientific rigor. Oversee the systematic collection of data from participants, implementing robust methodologies to guarantee accuracy and integrity. Additionally, analyze the gathered data using advanced statistical techniques to draw meaningful conclusions and insights, ultimately contributing to the advancement of medical knowledge and improving patient outcomes.
· Initiates start-up and training tasks for new study staff; registers for trainings (EPIC, CITI, ONCORE, Rush Internal Review Board (IRB) portal, Rush mandatory safety training); creates yearly goals for new staff and others as delegated by the Research Manager; completes the 30- and 90-day evaluations for new staff; sets up meetings often during the initial training period to ensure proper procedures and policies are learned; completes mid and yearly performance reviews.
· Works directly with the Finance Director and/or the Research Manager to help solve problems when issues arise; assists the Research Manager with overall disciplinary functions for all study staff; leads staff meetings to communicate upcoming regulatory issues, special events, and other topics relevant to the current research projects.
· Monitors and audits research staff work to ensure clinical research activities are conducted in accordance with ICH GCP guidelines, FDA regulations and guidance documents; creates and updates Rush’s SOPs, departmental SOPs, and applicable federal and state regulations and guidelines; identifies regulatory and compliance issues; and provides guidance, direction, and/or training when necessary to reduce or eliminate errors in the performance of clinical trials.
· Attends meetings with leadership to stay current on new and updated information shared by entities that function within Rush (regulatory, compliance, revenue cycle, sponsor invoicing, legal, 3rd party vendors, etc.), and outside entities (FDA, pharmaceutical companies, foundations, etc.) that communicate new
policies, processes, or guidelines; shares findings to study staff and other members of the research team, as needed.
· Supports Principal Investigators (PIs) with submissions for investigational new drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA; and coordinates regulatory activities for Rush-led multi-site research protocols including management of ClinicalTrials.gov web pages.
· Maintain documentation of staff credentials and qualifications (e.g., CVs, licenses, GCP, Certificates) and facilitate updates and/or renewal as required.
· Directs the preparation for audits and local monitoring visits; acts as the regulatory representative for all external and internal audits; prepares study staff in all aspects of audits: internal audits, sponsor audits, and FDA inspections of research studies; clinical trial processes: site qualification visits, (SQV), site initiation visits (SIV), interim monitoring visits (IMV), and close-out visits.
· Tracks, audits, and reports about submissions to ancillary committees such as Protocol Review and Monitoring Committee, Radiation Safety Committee, Investigational Pharmacy, and Institutional Biosafety Committee.
· Serves as a backup to the Research Manager as needed; assumes all duties of a regulatory coordinator, and other duties as needed; orders supply for clinic, research, and office.
· Other duties as assigned.
Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.