Job Description

Job Summary:

This position is part of an interdisciplinary research team consisting of staff and faculty in the Department of Orthopaedic Surgery. The coordinator manages daily operations of a biomedical research study involving colleagues, sponsors & other external project stakeholders, including the following: Monitors study performance, analyzes & review results, & supervises development & implementation of new protocols. Assigns work & supervises study staff & reviews technical operations ensuring that all processes, protocols & procedures are quality controlled & functioning up to standards. Develops implements & administers budgets, grant & administrative procedures. 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).

Specific Responsibilities:

Technical

Leads execution & control of a biomedical &/or social science project or research study.
Coordinates processing & analysis of data, conduct of experimental tests & procedures
Develops new &/or revised research methodologies.
Ensures completion of study activities per protocol including recruitment.
Ascertains pretreatment & eligibility requirements.
Obtains informed consent.
Registers participants with appropriate sponsor.
Interviews & obtains medical & social histories.
Collects data from medical records.
Administers, schedules &/or scores tests.
Administration

Oversees & manages collection, maintenance, analysis & evaluation of data that will be used in grant submissions, presentations & publications.
Ensures that information is entered correctly into databases.
Assists PI in reviewing, analyzing, interpreting, summarizing, formatting, editing, & preparing tables, charts, graphs, progress & final reports, etc.
Coordinates between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
Finance

Manages lab/study budget & inventory including purchasing of supplies & services ensuring that they are necessary, reasonable & project related.
Orders & maintains inventory of study supplies.
Distributes intra-departmental charges.
Negotiates with vendors, obtain quotes & arrange for demos of large equipment.
Supervision

Trains, directs, assigns duties to & supervises research staff, students, residents &/or fellows.
Acts as a mentor in regard to education of junior coordinators.
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 3 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 NU's IRB CITI training before interacting with any participants & must re-certify every 3 years