Manager Research Regulatory Affairs

Sarah Cannon Research Institute•Nashville, TN

10d

About The Position

As the Manager of Regulatory Affairs, you will oversee all aspects of the regulatory operations for Sarah Cannon Site Clinical Operations and manage the Regulatory Department. You will be responsible for developing and implementing short and long term strategies for the regulatory compliance for the site Clinical Operations. You will ensure Sarah Cannon adheres to and maintains Food and Drug Administration (FDA) regulatory compliance as well as oversees any regulatory audit. You will work closely with the department directors and/or primary investigators, industry sponsors and other outsides entities.

Requirements

A Bachelor’s Degree
Knowledge of scientific and clinical research terminology
Knowledge of FDA and GCP guidelines
Knowledge of organizational policies, procedures, and systems.
At least three years of experience in regulatory affairs
At least on year of experience in a supervisory role

Responsibilities

Manage, directs, plan and schedule activities and programs for the regulatory department
Establish and enforce procedures that assure all trial teams and sites are fully compliant with all applicable laws, regulations, standard operating procedures (SOPs), and other applicable guidelines
Develop and implement 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
Manage the regulatory affairs between the organization for multiple clinical trials according to FDA and Good Clinical Practice (GCP) guidelines; for individual sites, studies, sponsors and/or other networks
Manage 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
Resolve key regulatory issues with Pharmaceutical Industry Partners and Government Agencies
Develop and implement an approved archiving system for study specific regulatory documentation and correspondence
Apprise management of important regulatory issues and obtains guidance when necessary
Attend network meetings, conference calls and monthly staff meetings as appropriate
Visit strategic sites and provides training and mentoring as needed
Provide proactive and creative recommendations on how to meet goals and handle identified deviations
Responsible for objective setting, performance management, education and training of the regulatory staff, including developing Lead Regulatory Affairs Specialists
Responsible for implementing, managing, and refining departmental processes, and coordinating with clinical personnel around the conduct of research and client service issues
Initiates improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects