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: $32.00 - $52.08 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 Program Manager oversees a team of Clinical Research Regulatory coordinators within the Department of Pediatrics, serving as a mentor and providing support and training to ensure that the 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 sponsoring industry/pharmaceutical protocols and FDA guidelines, and maintaining collaboration with 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 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 multi-task 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; excellent written and oral communication skills.
• Proficient using Microsoft Office suite and other computer programs.
Preferred Job Qualifications:
• Master’s degree preferred.
• Prior supervisory experience preferred.
Responsibilities:
• Develops and oversees a team of regulatory coordinators; leads regular timely meetings to track the progress of study regulatory activities including study start-up, maintenance, and close-out activities; and provides direct feedback to team members (regulatory documentation completion and IRB submission preparation and requirements).
• 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.
• Train new study coordinators to ensure they are set up for success; register new study staff for training (EPIC, CITI, ONCORE, Rush Internal Review Board (IRB) portal, and other Rush mandatory training); create yearly goals with new study staff; complete the 30- and 90-day evaluation; set up meetings often with new study staff during the training period to ensure proper procedures and policies are learned; evaluate study staff during mid and yearly performance reviews.
• 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 potential issues or risks, and develop mitigation strategies to ensure that studies are completed on time and within budget.
• Attend meetings regularly 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) and facilitate updates and/or renewal as required.
• Assists study staff with preparation and oversees all aspects of audits: internal audits, sponsor audits, and FDA inspections of research studies and/or clinical trial processes, site qualification visits, (SQV), site initiation visits (SIV), interim monitoring visits (IMV), and close-out visits.
• Works directly with the Research Manager to help solve problems when issues arise, review meeting content, place orders for supplies, review budgets and contracts, plan events, and other duties as needed.
• Ensure that all communications related to the study are crafted with clarity, conciseness, and professionalism. This includes regular updates that keep Leadership, participants, and team members informed about the study's progress and any significant outcomes.
• Participate in the creation of new clinical research initiatives and explore potential opportunities that align with our organization's goals. Moreover, represent the organization effectively at clinical research conferences and events, showcasing our research findings, networking with other professionals, and engaging in discussions that may lead to collaborations and advancements in the field.
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.
Salary : $32 - $52
