Manages daily operations of a biomedical &/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders. Monitors study performance, analyzes & review results, & supervises development & implementation of new protocols. May assign work & supervise study staff & reviews technical operations ensuring that all processes, protocols & procedures are quality controlled & functioning up to standards. May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).

This position is responsible for overseeing, organizing and implementing multiple clinical research trials being conducted .This individual ensures appropriateness of patients supervises data collection and reporting, patient management and ensures adherence to all regulatory requirements and sponsor protocols. In addition, this individual will act as a resource to research study patients, physicians and other clinic personnel.

Specific Responsibilities:

Leads execution & control of a biomedical &/or social science project or research study.

Manages and ensures completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains 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 & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.

Reviews medical, laboratory, and other diagnostic data on study subject. Notifies principal investigator of any abnormal values or any significant changes in these values. Notifies and follows up with subjects as required.

Reviews any adverse events with assigned resource nurse and reports serious adverse events to principal investigator and sponsor in a timely manner. Follow up with subjects or subject family members in accordance with procedures. • Prepares for and completes close out procedures for terminated studies.

May Perform blood draws, EKG’s and other study specific procedures as required.