St. Joseph’s Healthcare System is recognized for the expertise and compassion of its highly skilled and responsive staff. The combined efforts of the organization’s outstanding physicians, superb nurses, and dedicated clinical and professional staff have made us one of the most highly respected healthcare organizations in the state, the largest employer in Passaic County, and one of the nation’s “100 Best Places to Work in Health Care”.
Responsible for monitoring ad recording clinical studies in accordance with the research protocol, federal regulations and guidelines, plus good clinical practices. Interacts with clinical investigators regarding the conduction of trials, processes data inquiries and interacts with hospital and contracted personnel. In a collaborative effort, works with physician investigators, nurse investigators, and patient care technicians, while using developed administrative knowledge and skills and applying research techniques in a health care environment.
Manages the initiation, progress, and conduct of the clinical trial to ensure the scientific integrity of the data collected and the protection of the rights, safety and well-being of human study subjects. Assists in protocol development and implementation. Ensures that all studies are conducted in full compliance with ICH GCP guidelines and HIPAA research collection. Maintains accurate and complete records of receipt, dispensing, and return of investigational products and all clinical supplies. Reviews, prepares, and submits regulatory documents and progress reports for IRB review and approval. Ensures that non-serious and serious adverse experiences are properly documented and reported. Maintains communication with study sponsor. Coordinates and maintains specimen collection, processing, shipping, and resultant data collection Meets all required competencies for department, unit and/or hospital. Responsible for performing all other duties as assigned. Special Projects
Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Medical Doctorate (MD) with research experience and less than one year of previous work related experience. MD license required. Work requires the analytical ability to resolve highly complex problems, requiring application of scientific, medical and technical principles in theories.