The Clinical Research Coordinator 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 in the Center for Clinical Research (CCR) of the Northwestern University Clinical and Translational Sciences (NU-CATS) Institute. 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.
**Please note: Some travel required throughout the year to attend investigator meetings or other study conferences. These meetings are not typically held within the immediate Chicago metropolitan area.
- 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.
- Perform blood draws, EKG’s and other study specific procedures as required.
- Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
- Includes completing data entry into study established Electronic Data Capture systems.
- Resolution of study queries.
- Manages project, collaborating and partnering with all internal/external staff including sponsoring agencies, organizations &/or other research &/or educational institutions to ensure project objectives and timelines are attained. Advises project staff on enhancements and changes to processes, practices, and procedures to ensure compliance with protocols and to increase effectiveness and efficiency of project.
- Ensures appropriate and timely compliance with associated local, state, & federal regulatory guidelines, requirements, & laws; & research protocols.
- Following Department Standard Operating Procedures (SOP’s) at all times.
- Performs other duties as assigned.
- Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a social or health science + 2 years’ experience; or 4 years practical research study or related experience; or a master's degree in a social or health science + 1 year experience is required. OR appropriate combination of education and experience.
- Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.
- Ability to become certified as a study coordinator within two years of employment in the department.
As per Northwestern University policy, this position requires a criminal background check. Successful applicants will need to submit to a criminal background check prior to employment.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes including veterans and individuals with disabilities.