Responsibilities
PRIMARY DUTIES AND RESPONSIBILITIES
Manage research projects assigned by the Research Program Director
Manage assigned departments/staff
Support Research Program with the development of appropriate goals, metrics and required documentation of project activities.
Identify collaborative opportunities across project teams, practices, and hospital departments.
Coordinate and lead meetings with NSH departments analyzing the feasibility of new research projects.
Ensure the quality and integrity of research.
Serve as a point of contact for Monitor visits from CROs, SMOs, and sponsors to help coordinate the visits with CRCs and CRNs and the availability of all necessary information to ensure accuracy and compliance.
Monitors all research activity and maintains awareness of all clinical research projects.
Provides compliance oversight for day-to-day operations
Develops, maintains, and evaluates the SOPs for administering clinical research
Conducts training on GCP, FDA, NIH, Human Subject Protection and necessary regulations.
ADDITIONAL DUTIES AND RESPONSIBILITIES
Resolve research conflicts during the normal course of business
Maintain professional knowledge and skills, particularly in the areas of Good Clinical Practice guidelines and other research regulations
Participate in the review, development and maintenance of automated processes and information technology for clinical research related activities
Develop, maintain, and deliver education and training programs for the NSH research community, protection of human subjects, the research life cycle, protocol development, monitoring visits, and others.
Other duties as assigned
Qualifications
KNOWLEDGE SKILLS AND ABILITIES/LICENSE OR CERTIFICATION REQUIRED
Bachelor's degree in a relevant field.MBA preferred.
Minimum of 5 years9 experience in a clinical research setting
Ability to correctly interpret laws, regulations and policies related to research compliance
Excellent organizational and project management skills with the ability to manage multiple tasks simultaneously
Knowledge of clinical trial policies and regulations and Good Clinical Practice (GCP)
Established interpersonal skills combined with the ability to be highly motivated and work independently
Demonstrated analytical and problem solving skills
Ability to work independently and as part of a team
Ability to manage teams of varying sizes
Knowledge of information technology systems supporting regulatory affairs, IRB and compliance research administration
Work Hours:8-5p
