Clinical Research Regulatory Compliance Manager-18057

Rush University Medical Center; Chicago (IL); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Clinical Research Regulatory Compliance Manager to lead a dedicated team within the Pediatrics department. This pivotal role involves ensuring compliance with clinical research regulations while mentoring and training staff. The ideal candidate will have extensive experience in clinical research, strong supervisory skills, and a deep understanding of regulatory frameworks. This position offers a unique opportunity to contribute to impactful research initiatives while collaborating with various departments. If you are passionate about regulatory compliance and ready to make a difference, this role is for you.

Qualifications

• Minimum of 7 years in clinical research, preferably in academic or pharmaceutical settings.
• Strong knowledge of CFRs, GCP, HIPAA, and related regulations.

Responsibilities

• Manage and develop a team of regulatory staff and oversee daily operations of research studies.
• Ensure compliance with GCP, FDA regulations, and prepare for audits and inspections.

Skills

Regulatory Compliance

Clinical Research

Supervisory Skills

Communication Skills

Microsoft Office

Education

Bachelor's Degree

Master's Degree

Job description

Clinical Research Regulatory Compliance Manager-18057

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Position Overview

The Clinical Research Regulatory Compliance Manager serves as a subject matter expert overseeing a team of Clinical Research Regulatory coordinators within the Pediatrics department. This role liaises with Principal Investigators (PIs), Industry Sponsors, the IRB, Compliance, and the Research and Clinical Trials Office (RCTA). The manager provides mentorship, training, and ensures compliance with clinical research regulations at site, state, and federal levels. Responsibilities include addressing regulatory issues, developing quality initiatives, and collaborating with various departments to support research activities.

Minimum Qualifications

• Bachelor’s degree required.
• At least 2 years of supervisory and regulatory experience.
• Minimum of 7 years in clinical research, preferably in academic or pharmaceutical settings.
• Relevant certifications such as CCRP, CCRA, CCRC, or CIP.
• Strong knowledge of CFRs, GCP, Helsinki Declaration, Belmont Report, and HIPAA.
• Excellent communication skills and proficiency in Microsoft Office.

Preferred Qualifications

• Master’s degree preferred.

Key Responsibilities

• Manage and develop a team of regulatory staff, including coordinators, nurses, and lab staff.
• Lead meetings, monitor study regulatory activities, and provide feedback.
• Oversee daily operations of research studies, including protocol design, data collection, and analysis.
• Coordinate staff training, evaluations, and performance reviews.
• Ensure compliance with GCP, FDA regulations, and SOPs; prepare for audits and inspections.
• Support PIs with regulatory submissions, including IND, IDE, and biologics applications.
• Maintain documentation of staff credentials and facilitate renewals.
• Act as a regulatory representative during audits and inspections.
• Track and report submissions to various committees.
• Perform other duties as assigned.

Additional Information

Location: Chicago, IL
Business Unit: Rush Medical Center
Department: Pediatrics-Res Adm
Work Type: Full Time (0.9-1.0 FTE)
Schedule: 8 AM - 4:30 PM, Shift 1
Pay Range: $55.16 - $80.05/hour
Benefits: Learn more at Rush benefits page

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 protected characteristics.