Clinical Research Regulatory Coordinator - Research Affairs

Location: Chicago, IL

Hospital: Rush University Medical Center

Department: Research Affairs-ResAdm

Work Type: Full Time (Total FTE between 0. 9 and 1. 0)

Shift: Shift 1

Work Schedule: 8 Hr (9:00:00 AM - 5:00:00 PM)

Rush offers exceptional rewards and benefits learn more at our Rush benefits page.

Summary:
This positions provides regulatory support for multiple clinical research studies, which may involve multi-centered cooperative group studies, single site studies, intergroup studies, industry studies, and investigator initiated studies. Prepares internal and external regulatory submissions throughout the conduct of the assigned studies. The incumbent exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.

Other information:
Required Job Qualifications:
• Bachelor's degree.
• 2-4 years clinical experience
• 2 years coordinating Human Subjects research.
• Must demonstrate proficiency with 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, and RUCC policies and procedures.
• Demonstrated problem-solving, critical decision makings and professional judgement.
• Strong analytical skill with a high attention to details.
• Clear and concise verbal and written communication with ability to communicate complex concepts for a wide range of individuals in a cross-functional environment.
• Demonstrated ability to collaborate within multi-disciplinary teams, customer service oriented
• Ability to meet deadlines and coordinate multiple aspects of the ongoing project.
• Ability to manage stressful situations.
• Proficiency with Microsoft Office Suite.
• Proficiency with Adobe Acrobat.
• Requires a commitment to customer service and the ability to work effectively and collaboratively in a complex academic environment.
Preferred Job Qualifications:
• Bachelor's degree in Health Sciences or related discipline.
• Master's degree in science or health related field.
• 2 years of years of clinical research experience, in the academic or pharmaceutical clinical trials environment.
• Relevant certification as a Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP) strongly preferred or required within 1 year of employment.

Responsibilities:
• Supports multiple clinical research studies, which may involve multi-centered cooperative group studies, single site studies, intergroup studies, industry studies, and investigator initiated studies.
• Writes and prepares IRB regulatory submissions, including but not limited to consent forms, new project applications, continuing review applications and unanticipated problems.
• Communicates with IRB and finalizes documents based on IRB comments and recommendations to ensure IRB approval of study.
• Coordinates submissions to ancillary committees such as Protocol Review and Monitoring Committee, Radiation Safety Committee, and Institutional Biosafety Committee.
• Provide ongoing study status updates, responds to questions and may create summary report(s) for distribution to PI, Administrator, Office of Research Affairs, Sponsor and Compliance throughout the conduct of the study
• Collaborates with study team to ensure implementation of amendments, awareness of safety, and protocol changes and document version control.
• Serves as the primary regulatory contact for studies to ensure that regulatory files are audit-ready.
• Works closely with the Office of Research Affairs and Research Compliance to ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance with study sponsor, Principal Investigator, and regulatory agency specifications.
• May collaborate with study investigators, nurses, study coordinators, and study sponsors to coordinate study start-up activities, which include collection and distribution of regulatory, budget, contract, and coverage analysis documents.
• Maintains accurate records related to the regulatory aspects of clinical research.
• May coordinate timely investigator assessment of safety reports.
• Proactively identifies regulatory issues and/or variances with study protocols and recommends process improvements.
• May train new research coordinators on basics of regulations applicable to clinical research and lead presentations.
• Maintains current knowledge of industry trends.
• Coordinates department or clinic compliance.
• Directs compliance documentation submission and maintenance.

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.