Director of Research

Job description

The Director of Clinical Research will provide oversight, leadership, and guidance in the management and execution of clinical research at a medical practice located in Atlanta, GA. This position will help to develop and maintain relationships with clients, develop and support staff, and oversee day to day operations of research department. RN or other medical professional designation required.

Tasks:

• Develop operating procedures and ensure that the entire research team follows those procedures. Evaluate new operational methodologies that would increase efficiencies, provide competitive advantage and reduce costs.
• Ensure that all federal and state regulations are followed completely.
• Handle HR roles including overseeing the hiring process and the employee management process. Develop succession and training plans for all direct reports and conduct annual performance reviews.
• Select, coach, counsel and develop all site staff to ensure they possess the necessary knowledge and skills to achieve operational and revenue objectives.
• Conduct monthly site meetings to communicate information, provide continuing education, training, and enhance teamwork.
• Ensure site is maintained in an attractive, safe, and efficient manner.
• Maintain comprehensive knowledge of all protocols being conducted.
• Perform quality reviews to ensure the adequate execution of protocols and ensure adequate site staff training as needed.
• Assist with the development and implementation of corrective and preventive actions to maintain a high quality site.
• Provide leadership and manage the study recruitment to ensure enrollment goals are met or exceeded.
• Direct and guide site staff on study specific tasks; assist in training staff.
• Establish rapport with sponsor representatives and maintain frequent face-to-face, written, and telephone contact with various persons involved in the study, including but not limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and all levels of the company
• Ensure the completion and timely return of feasibility and site qualification questionnaires to the Pharmaceutical Companies/CROs
• Administrative oversight of all regulatory aspects of trials
• Review and completion of NDAs
• Participate in the design, development and review of clinical trial protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents and study reports
• Oversee invoicing and confirm payment of study expenses, such as IRB fees, vendor fees, and study subject payments