The Clinical Research Coordinator I (CRC I) supports the clinical departments and the Central Research Department (CRD) conducting research at Northside Hospital. Responsibilities involve patient registration, data collection, data submission, adverse event reporting, patient follow-up, records management, regulatory reporting, quality assurance and other activities related to research. The CRC I works closely with the Research Team to complete all research required services. Additionally, the CRCI will assist the Research Finance Team to facilitate accurate patient registration and billing
PRIMARY DUTIES AND RESPONSIBILITIES
- Review and verify subject eligibility based on study inclusion/exclusion criteria
- Identify, recruit and screen potential clinical study participants
- Obtain informed consent from patients in coordination with the Investigator
- Coordinate clinical care with investigator pursuant to the protocol, and in accordance with hospital policy
- Coordinate, and perform, clinical procedures during research visits (i.e. vital signs, blood draws, EKGs, drug administration, drug dispensing, and other clinical activities as necessary and capable) in conjunction with appropriate training/certification and following hospital policy. Assists clinical staff responsible for research patient visits to complete the research requirements
- Coordinate diagnostic tests including laboratory tests, radiologic tests, and other tests required by the study
- Coordinate the collection and processing of research specimens: blood, urine, tissue, etc., to ensure adherence of protocol requirements
- Identify, evaluate, and complete all adverse events and severe adverse events and report accordingly with the assistance of the research team
- Secure patient records and source documentation for sponsor monitoring and internal/external audits
- Communicate with study sponsors m collaboration with the research team and investigator
- Assure that all federal, state, local, and hospital laws and regulations are adhered to, as they relate to the protection of human subjects and to research compliance
- Provide backup coverage for other Research Team members when necessary (travel to other sites may be required)
- Obtains, and maintains database Enters data as needed.
- Practices proper safety techniques in accordance with hospital and departmental policies and procedures and immediately reports any mechanical or electrical equipment malfunctions, unsafe conditions, or employee, patient, visitor injury or accident to the assigned Manager.
