The Director of Clinical Research will provide oversight, leadership, and guidance in the management and execution of clinical research at Atlanta Diabetes Associates. Will help to develop and maintain relationships with clients, develop and support staff, and oversee the day-to-day operations of the research department. JOB CLASSIFICATION Salaried Exempt Tasks: Develop operating procedures and ensure that the entire research team follows those procedures.
Evaluate new operational methodologies that would increase efficiencies, provide a competitive advantage, and reduce costs. Ensure that all federal and state regulations are followed completely. Handle HR roles alongside HR Department, including overseeing the hiring and employee management processes. 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 the 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 and study contracts 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 Investigator-initiated study protocols
Skills and Qualifications:
Working Conditions:
Work is predominately performed in an office, laboratory, and/or clinic environment, with occasional work from home. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. Management retains the right to add or change the duties of the position at any time.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
This company appears to be a placeholder or an internal identifier, as no specific business information can be derived from the provided name.