Green Card Senior Regulatory Affairs Specialist Jobs

INTRODUCTION

It’s More Than a Career, It’s a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

ROLE AND RESPONSIBILITIES

The Senior Manager for Research Regulatory Affairs is responsible for the overall operations of, which include but is not limited to Regulatory Affairs Specialist, Conflict of Interest, Safety, Process Specialist. This individual will also work very closely with study activation site research teams, protocol research operations, budget, and contract department, and finance to continue evaluating our regulatory processes and metrics to ensure regulatory is working as efficiently as possible to meet or exceed our goals. In this role, the individual must have managerial and leadership skills as well great customer service skills to comfortably interact and communicate with internal teams, pharma/CRO teams, IRBs, site research teams and our physicians. The Senior Manager:

• Oversees the regulatory start-up and maintenance of trials; including safety and conflict of interest
• Works closely with our research sites, study activation, research protocol operations, budget, and contracts team
• Develops and implements regulatory policies and procedures for the sites and the site Clinical Operations team; including managing and planning regulatory affairs compliance for industry sponsors and/or sites
• Manages the regulatory affairs between the organization for multiple clinical trials according to FDA and GCP guidelines; for individual sites, studies, sponsors and/or other networks
• Manages the relationships between industry partners and the FDA regarding regulatory compliance for the organization and managing regulatory audits of studies by sponsor/industry and governmental auditors
• Problem solves with the department managers and other site leadership as they arise
• Assists in developing and executing the Sarah Cannon internal and external strategies
• Provides oversight, leadership, and direction in the regulatory study startup of trials and in maintenance areas where support is provided
• Assesses organizational processes associated with regulatory startup and support to identify ways to improve and streamline processes
• Meets with site leadership as needed to ensure contracted services are being provided by the teams
• Accountable for leading people, setting direction, and deploying resources; responsible for attracting and selecting talent; support onboarding new employees to decrease time to productivity; driving performance through their team members by setting direction, providing feedback, and creating a trust-based, inclusive work environment; developing employees through coaching and feedback; rewarding and recognizing employees via ongoing recognition and core pay-for-performance practices are primarily achieved through the work of others and typically depend on the manager's ability to influence and negotiate with parts of the organization where formal authority is not held.
• Develops metrics and reports KPI on weekly and monthly basis to department managers to ensure targets initiatives are being met.
• Investigates complex and unusual customer requests and complaints, develops remediation plan and leads implementation.
• Provides leadership and direction to employees either through other managers or directly to employees.
• Develops, adapts, and executes functional or departmental strategy to achieve key business objectives in area of responsibility.
• Keeps executive and management team abreast of issues, progress, and risks related to regulatory affairs
• Develops, implements, and evaluates programs to promote recruitment, retention, and continuing education of the team
• Attends and participates in all required meetings including weekly operational review and Director’s meeting
• Assists in development and tracking of department goals and metrics
• Works closely with monitors, sponsors/CROs, sites, and team to ensure quality and timely work being delivered
• Support and collaborate with IRB counterparts to ensure quality relationships
• Represents company vision to colleagues and external customers
• Tracks and communicates to team and sites performance expectations and status
• Works with other members in Research Operations to ensure communication and responsibility are effective and appropriate
• Adhere to professional standards and SOPs established for clinical research and develop new SOPs and or Working Practice Guidelines as appropriate. Monitor adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required.
• Participate in educational activities and programs
• Maintain strictest confidentiality
• Provide proactive and creative recommendations on how to meet corporate and role-specific goals and handle identified deviations
• Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management
• Provide high level customer service, support and problem resolution to ensure the delivery of organizational goals

BASIC QUALIFICATIONS

You should have for this position:

• A Bachelor’s Degree preferably a Master’s Degree
• At least three years of Research experience either on the site side or within industry
• At least three years of Management with direct reports
• Research certification (ACRP or CCRP) is preferred

ABOUT SARAH CANNON RESEARCH INSTITUTE

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. to learn more about our research offerings.

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson,

As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

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