Summary

The regulatory manager is responsible for leadership and overarching departmental expectations and practices for the regulatory team composed of 2 regulatory supervisors and 17 Research Regulatory staff members.
• The goal for this position is to monitor team performance measures, identify, report on, and respond to trends, recognize opportunities for improvement, and facilitate and implement solutions related to team functions and regulatory compliance.
• Key areas include activation and amendment timelines, process improvement, change management, work quality, and staff performance. This individual sets the tone for the team, including CTO priorities of ownership, urgency, timeliness, and accountability, proactive actions, and effective (articulate yet concise) communication.

Primary Responsibilities

• Functional manager representing the Regulatory Team at meetings with partner organizations as well as internal process discussions. Works collaboratively with principal investigators, sponsors, study team members, and representatives in other departments and institutions, maintaining open communication.

• A resource for investigators and support staff on pre-trial and ongoing trial maintenance functions, including gathering regulatory documents, safety committee reviews, assisting with IND applications, IRB applications, trial amendments, annual progress reports, CT.gov applications and maintenance, etc., as specific to clinical trials. Advise study investigators and support staff on administrative and regulatory aspects of human subject research.

• Responsible for time, workload, and performance management for the regulatory team.

• Recruit and train clinical research staff on regulatory issues; develop and implement standardized expectations for all subordinates; assess, monitor, and evaluate workload, timelines, competencies, and performance. Collaborate with Education/QA team on the development of training materials and quality assurance activities to ensure success and compliance. Mentor and direct staff to achieve research goals.

• Maintain protocol activation timelines, including tracking deadlines for program components. Utilize the Clinical Trial Management System (CTMS) OnCore and other systems to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.

• Manage other data systems, such as Florence, RightFax, and eBridge, which support research activities. Correspond with local and central IRBs as needed.

• Develop and implement departmental policies, procedures, and organizational tools to ensure compliance with institutional standard operating procedures and procedural guidelines, as well as state and federal standards.

• Identify problems or obstacles in the system/procedures related to implementation of research protocols and communicate with study investigators.

• Act as a liaison between department leadership and research staff. Work closely with other departments and external agencies to advance the department's research goals.

• Develop, implement, and monitor departmental research QI activities. Implement and conduct quality control processes to ensure the highest data and research standards.

• Develop clinical data review plans and check specifications. Utilize quality improvement tools & statistical process control to facilitate improvement of systems & processes.

• Perform as a regulatory specialist/coordinator for select projects as needed.

• Coordinate notifications to study team members regarding annual regulatory education requirements.

• Coordinate program outreach activities, acting as a liaison with community organizations and providing regulatory support for applicable research sites.

• Other duties as assigned.

Knowledge - Skills - Abilities

• Knowledge of basic science and mathematics, documentation, and records management.

• Working knowledge of e-Bridge, electronic IRB and Grants and Contracts functions. Excellent oral and written communication skills are essential.

• Strong critical thinking, problem solving and attentiveness to detail required.

• Strong computer skills.

• Sufficient knowledge of program study area.

• Strong leadership and staff oversight and management skills are critical.

• Data utilization, complex problem solving, critical thinking, resource management, and writing skills.

Qualifications

Appropriate experience may be substituted for education on an equivalent basis.

Minimum Required Education: Bachelor's degree

Minimum Required Experience: 6 years of experience in research program coordination or regulatory.

Preferred Education: Experience with program management in a medical research or educational environment preferred.

Preferred Experience: Prior work with clinical research or regulatory or patient care preferred.

Required Certification/Licensure(s): CCRC or CCRP required. CITI training required within 90 days of hire.

Preferred Certification/Licensure(s):

Physical Requirements

Work requires occasionally lifting moderate weight materials, standing, or walking continuously.

Work Environment

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.

Sensory Acuity

Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.

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