Title: Clinical Research Manager
Manages daily operations of a biomedical and/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors and other external project stakeholders. Monitors study performance, analyzes, review results, and supervises development and implementation of new protocols. Assigns work and supervises study staff and reviews technical operations. The Clinical Research Coordinator will ensure all processes, protocols and procedures are quality controlled and functioning up to standards. May co-author scientific papers for presentation and publication. Will coordinate writing, submission, administration of grants. Ensure all study activities are completed by strictly following Good Clinical Practices (GCP), all current local, state, and federal laws, regulations, guidance, policy and procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH).
- Lead the execution of a biomedical, social science project and/or research study.
- Manages and ensures completion of study activities per protocol. Will collaborate with nursing staff and Principal Investigator (PI) to ascertain pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient’s treatment and test schedules.
- Manages conduct of experimental tests & procedures. Closely monitors & document patient’s adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.
- Internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
- Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
- Manages system for perpetration of effective data flow for oncology research clinical trials and chemo-prevention studies.
- A bachelor’s degree in social or health science + 2 years of relevant experience; or 4 years of practical research study or related experience; or a master’s degree in a social or health science + 1 year experience