Department: MED-Ophthalmology
Salary/Grade: EXS/5

Job Summary:

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 department of Ophthalmology. 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.

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.

Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.

Specific Responsibilities:

Technical

• 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.

Data

• 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.

Administration

• 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.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• 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 major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR
• Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 1 year research study or other relevant experience.
• Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.

Preferred Qualifications:

• Ability to become certified as a study coordinator within two years of employment in the department.

Target hiring range for this position will be between $55,000-68,000 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

Benefits:
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