Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Occupational Summary
Coordinate and supervise personnel and activities engaged in primarily exercise research studies for research participants within a specialized area at Duke University Medical Center; coordinate research and contracted activities.
Work Performed
• Supervise, plan, evaluate, and implement exercise studies for research participants within a specialized area through the utilization of procedures including maximal and submaximal exercise testing on a treadmill/cycle ergometer using a metabolic cart, strength testing (Universal and isokinetic dynamometry (Biodex)), cardiac and vascular ultrasound studies, body composition measurements, administration of metabolic studies (e.g. oral glucose tolerance testing, stable isotope infusion), resting indirect calorimetry, and other related activities.
• Take patient histories; conduct physical examinations; administer selected tests to include exercise stress, body density, electrocardiogram and blood tests to determine appropriate program which includes an individualized program of aerobic/resistance exercise, diet planning and instruction concerning modification of behavioral patterns to include smoking, eating and adherence to medication.
• Monitor the progress of individual research participants in the performance of prescribed exercise regimens to include personal motivation as well as assessment of participants tolerance of exercise program.
• Develop monitoring techniques and specialized types of exercise equipment to satisfy needs of the program; supervise maintenance of exercise testing equipment.
• Maintain records reflecting up to date participant progress, programs and related statistical data as required by departmental policies; evaluate collected data and provide reports to principal investigator.
• Explain plan and procedures to participants to allay fears and to elicit cooperation in gaining the maximum benefit from the program; plan post program follow-up to assist in carrying out maintenance program.
• Conduct physical, chemical or biological tests, experiments and determinations to obtain data in support of research oriented activities; compile and document procedures and results.
• Provide staff development and training in exercise testing technology and physiology; develop and implement quality assurance standards.
• Coordinate the collection, analysis, interpretation and documentation of all data generated by the research laboratory research projects. Compile and maintain records, reports and documentation of data and procedures.
• Assist PIs and Grant Managers in the development and submission of accurate proposal budgets and compliant proposal materials by interpreting sponsor guidelines, University policies and Federal regulations.
• Coordinate research participant recruitment and scheduling for research study procedures and exercise interventions.
• Assist PIs in grant and scientific paper writing and review of the literature.
• Screen participants for complex studies (e.g., procedural and interventional studies). Develops or helps develop SOPs.
• Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary.
• Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings.
• Collects, prepares, processes, ships, and maintains the inventory of research specimens.
• Develops consent plans and documents for participants in a variety of studies. Develops and submits documentation and information for Institutional Review Board (IRB) review. Communicates with the IRB staff and reviewers and handle issues appropriately. Identifies all adverse events (AEs), and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
• For studies with complex supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Uses systems and system reports to manage research participants activities and charge routing. Prepares studies for closeout and document storage. Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
