Director of Regulatory Affairs for Clinical Research

  • HCA
  • Nashville, TN, USA
  • Apr 25, 2018
Healthcare

Job Description

Job Code: 03058-SARA010

Full-time

Days (rotating weekends)

Sarah Cannon is the research arm of HCA’s global cancer enterprise. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.

We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.




Summary of Key Responsibilities: The Director of Regulatory, is responsible for the overall operations of the regulatory team and ensuring its quality and timeliness. This individual will work very closely with the other Site Support teams, such as the Study Activation and Budgets and Contracts departments, to continue evaluating our study start up processes and ensure all teams are 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, and site research teams and our physicians.




Duties and Responsibilities:
  • Oversee the regulatory team and foster a collaborative environment
  • Works closely with our research sites and internal teams
  • Assesses organizational processes associated with startup and support to identify ways to improve and streamline processes
  • 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 study startup of trials and in maintenance areas where support is provided
  • Meets with site leadership as needed to ensure contracted services are being provided by the teams
  • Keeps executive and management team abreast of issues, progress, and risks related to support operations
  • 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
  • Represents company vision to colleagues and external customers
  • Tracks and communicates to team and sites performance expectations and status
  • Works with other members in Clinical 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


Knowledge:
  • Knowledge of organizational policies, standard operating procedures, and systems
  • Knowledge of regulatory requirements for clinical research
  • Strategic planning skills

Skills:
  • Computer skills
  • Public presentation skills

Abilities:
  • Interpersonal, communication, and organizational skills
  • Commitment to individual and team success
  • Fosters a collaborative working environment

Education:
Bachelor Degree required

Experience:
  • At least three years of experience of research experience either on the site side or within industry
  • At least three years of management experience with direct reports


Certification or License:

Research certification (ACRP or CCRP)

Last Edited: 04/24/2018

Reference

03058-SARA010