A study coordinator is a specialized researcher who supports the management and coordination of clinical research studies. Are you interested in research and clinical investigation? Do you have a keen attention to detail? If so read on to discover what it is like to work as a study coordinator.
What is a Study Coordinator?
The study coordinator works under the guidance of the Clinical research investigator to manage daily activities of clinical research. Typical duties of a study coordinator include:
- Coordination of clinical research to ensure research activities comply with federal guidelines and institutional policy
- Ensuring proper training of research personnel to comply with federal guidelines
- Recording and documenting training activities of personnel
- Working closely with compliance officers facilitating and reporting on clinical audits
- Maintaining confidentiality and protection of patients participating in clinical research, ensuring informed consents are obtained for all participants
- Documenting and reporting any breach in compliance with federal and agency regulation to appropriate persons
Characteristics of an effective study coordinator include the following:
- Ethical work practice
- Excellent research skills
- Attention to detail
- Critical thinking skills
- Knowledge of budgeting and financial principals
The nature of the work of a study coordinator involves overseeing the research process from inception to completion. The study coordinator is the key person to ensure the safety and protection of human subjects. The study coordinator prepares documentation for Institutional Review Board approval. The study coordinator prepares the budget for the study and collaborates with the funding agency to allocate appropriate funding for all aspects of the clinical research.
The study coordinator is involved with patient recruitment and participation in the clinical research. The coordinator will oversee patient involvement and be responsible for reporting any adverse events occurring during the clinical research. The study coordinator may be responsible for drafting informed consent documents and ensuring all patients have completed these forms.
The study coordinator will collaborate with the principal investigator and all members of the research team to ensure proper training is received by all personnel. The study coordinator will maintain appropriate documentation of training activities. The study coordinator will manage documentation as required by institutional and government agencies.
The study coordinator will be well informed of inclusion and exclusion criteria for patient subjects. The coordinator will be involved in screening potential subjects. The study coordinator coordinates research activities of participants. The study coordinator completes case reports using appropriate data generated by the research.
The study coordinator manages inventory and ensures appropriate supplies are available to conduct all activities. The study coordinator communicates with financial partners throughout the research process. The study coordinator is responsible for reporting outcomes to all parties including institutional and government agencies as well as funding sources. The study coordinator will follow ethical guidelines and report appropriately any adverse outcomes.
The study coordinator works with the principal investigator to prepare and deliver findings of the study to appropriate agencies. The study coordinator handles the maintenance of documents for a specified time after the study as dictated by institutional policy or federal regulation.
The study coordinator will work in any institution conducting clinical research. Study coordinators are often employed by research hospitals, educational facilities, laboratories, pharmaceutical companies, or government agencies. Work hours may be long. The study coordinator will typically be a full time position.
Education and Training
Typically the study coordinator will have a Bachelor’s degree in science, biology, chemistry or a related field. Experience in clinical research will likely be a requirement for the position. The Bureau of Labor Statistics keeps statistics on medical and clinical laboratory technicians and the responsibilities of this position are most closely related to the study coordinator. According to the Bureau of Labor statistics about 50% of medical and clinical laboratory technicians work in the hospital setting. The average salary of a medical laboratory technologist in 2012 was $57,580 annually. Salaries will vary depending on location and institutional budget. The Bureau of Labor statistics reports an increased demand for medical and clinical technologists in the coming years as a result of the increase in the elderly population in the United States as the baby boomers grow older. This will create an increased demand for research regarding chronic illnesses. A 22% growth in the demand of medical and clinical technologists is projected between 2012 and 2022.