Cardiology Regulatory & Quality Lead

Columbia University in the City of New York; New York (NY); Hybrid; USD 71,000 - 73,000; Full time

Job summary

Columbia University is seeking a Regulatory Manager to provide regulatory oversight across clinical portfolios. You will lead staff, ensure audit readiness, and enforce documentation standards in alignment with FDA, ICH-GCP, and sponsor requirements.

The role emphasizes strategic and operational management of regulatory activities, with responsibilities spanning submissions, oversight, and continuous process improvement within a university research environment.

Qualifications

• Bachelor's degree or equivalent with experience in clinical research regulatory roles.
• Strong knowledge of ICH-GCP, FDA regulations, and sponsor frameworks.
• Experience overseeing audit preparation and risk mitigation.

Responsibilities

• Oversee regulatory lifecycle across protocols, start-up to closeout.
• Prepare submissions and monitor approvals; coordinate IRB processes.
• Lead audit readiness and CAPA activities with leadership.
• Develop and implement regulatory documentation standards and workflows.
• Provide supervision and development for staff; report to leadership.
• Monitor compliance metrics and produce periodic quality reports.

Skills

Regulatory leadership

Quality assurance

Project management

Education

Bachelor's degree

Tools

Regulatory tracking systems

Microsoft Office

Job description

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $71,400 to $73,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Regulatory Manager provides operational and strategic oversight of regulatory compliance and quality assurance activities across assigned clinical research portfolios.

This role supervises regulatory staff, ensures audit readiness, mitigates compliance risk, and implements standardized documentation and monitoring processes aligned with institutional, sponsor, and federal requirements.

The Regulatory Manager holds accountability for regulatory infrastructure, documentation standards, audit outcomes, and staff performance within the assigned research environment and serves as the primary escalation point for regulatory and quality concerns.

Responsibilities

• Oversees regulatory lifecycle management across assigned protocols, including start-up, maintenance, and closure activities.
• Prepares consent forms, monitor date of approvals and communicate to research coordinators at the time IRB approves and stamps new consents.
• Prepares submissions for the Joint Radiation Safety Committee and oversees submission of JRSC annual submission (being incorporated into RASCAL).
• Prepares Cost Estimates for research pharmacy, radiation and anesthesiology in collaboration with finance manager.
• Provides final review and approval of complex submissions and compliance documentation as required.
• Participates in investigator meetings, site initiation visits and monitoring visits, if needed.
• Implements and monitors quality control mechanisms to ensure consistency, accuracy, and audit readiness of regulatory documentation.
• Serves as escalation authority for high-risk regulatory issues and quality concerns.
• Ensures adherence to institutional policies, HIPAA, ICH-GCP, FDA regulations (21 CFR), OHRP guidance, sponsor requirements, and local/state compliance frameworks.

Quality and Monitoring Support

• Oversees preparation and execution of sponsor monitoring visits, internal audits, federal inspections, and accreditation reviews.
• Reviews audit findings and approves corrective and preventive action (CAPA) plans.
• Monitors resolution of compliance findings and ensures systemic process improvement.
• Analyzes audit trends and compliance metrics to identify recurring risks and operational vulnerabilities.
• Provides periodic compliance and quality reports to leadership.

Process Improvement

• Develops, implements, and revises regulatory and quality workflows, SOPs, templates, and documentation standards.
• Identifies inefficiencies, documentation gaps, and compliance vulnerabilities and implements corrective process enhancements.
• Leads initiatives to standardize regulatory documentation and monitoring frameworks across research teams.
• Collaborates with research leadership to improve operational consistency, reduce audit risk, and enhance regulatory infrastructure.
• Supports development of tracking tools and dashboards to monitor regulatory performance indicators and quality metrics.
• Participates in institutional committees related to research compliance, governance, and quality initiatives.

Compliance and Documentation

• Ensures assigned research portfolio maintains complete, accurate, and audit-ready regulatory documentation at all times.
• Oversees documentation standards across regulatory systems and shared repositories.
• Monitors adherence to federal, state, institutional, and sponsor documentation requirements.
• Establishes documentation review processes to ensure consistency and regulatory accuracy.
• Escalates significant compliance risks and documentation deficiencies to senior leadership with recommended mitigation strategies.
• Maintains awareness of evolving regulatory requirements and ensures appropriate implementation within the department.

People

• Provides direct supervision to Research Regulatory & Quality Coordinators, Specialists, and/or Senior Specialists.
• Responsible for recruitment, onboarding, training, performance management, and professional development of staff.
• Conducts performance evaluations and establishes measurable goals aligned with compliance standards and departmental priorities.
• Promotes cross-training and workload balancing across team members.
• Identifies performance concerns and partners with Human Resources on remediation and development plans.
• Fosters a collaborative, accountable, and compliance-focused team culture.
• Partners with investigators, research administrators, compliance offices, and institutional stakeholders to ensure regulatory alignment.
• Serves as departmental liaison to institutional IRB, compliance offices, sponsors, and external regulatory bodies.
• Provides consultation to research teams regarding complex regulatory and quality matters.
• Supports implementation of institutional research policies and regulatory updates.

Other

• Maintains current completion of required organizational, compliance, and research-related trainings.
• Performs other tasks as required and assigned within scope of work.

Minimum Qualifications

• Bachelor's Degree or equivalent in education and experience, plus four (4)years of progressive experience in clinical research regulatory and/or quality roles.
• Advanced knowledge of ICH-GCP, FDA regulations (21 CFR), OHRP guidance, IRB processes, and sponsor regulatory frameworks.
• Proficiency with Microsoft Office applications and willingness to learn research systems (e.g., IRB platforms, regulatory tracking systems, EMR).
• Demonstrated experience overseeing audit preparation and compliance risk mitigation.
• Strong leadership, organizational, and decision-making skills.
• Must be a motivated individual with a positive mindset and exceptional work ethic.
• Ability to work with a variety of individuals and groups in a constructive and respectful manner while appreciating the unique contributions of an inclusive workforce that brings together the talents of people across multiple identities.
• Excellent organizational skills, time management and the ability to set priorities among multiple competing objectives, tasks and initiatives is required.

Preferred Qualifications

• Years of supervisory or formal team leadership experience.
• Certification as a Clinical Research Professional (ACRP, SOCRA, RAPS, PRIM&R CIP).
• Experience managing Sponsor-Investigator submissions.
• Experience within academic medical center research environments.
• Experience developing compliance dashboards and regulatory reporting frameworks.

Other Requirements

• Must successfully complete systems training requirements.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.