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. 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).
This role will support clinical research that seeks to improve lung function in patients with cystic fibrosis (CF).
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.
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.
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.
Manages lab/study budget & inventory including purchasing of supplies & services ensuring that they are necessary, reasonable & project related.
Orders & maintains inventory of study supplies.
Trains, directs, assigns duties to & supervises research staff, students, residents &/or fellows.
Acts as a mentor in regard to education of junior coordinators.
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 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.
Supervisory or project management experience required.
Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
Minimum Competencies: (Skills, knowledge, and abilities.)
Ability to successfully complete the requirements of the Northwestern Memorial Hospital Research Access Program.
Prior working experience with IRB preparation and submission.
Prior working experience with REDCap.
Preferred Competencies: (Skills, knowledge, and abilities)
Skill/ability in use of standard computer programs (Microsoft Excel, Outlook, and Word) and navigation of the internet.
Ability to seek certification as a clinical research coordinator.
Action oriented - Willing or likely to take practical action to deal with a problem or situation.
Coachability - Receptive to feedback, willing to learn, embracing continuous improvement.
Collaboration - Facilitates open and effective communication, cooperation and teamwork within and outside of one's own team.
Collegiality - Helpful, respectful, approachable; builds strong working relationships and a positive work environment.
Initiative - Exhibits energy and desire to achieve; sets ambitious goals and acts decisively; takes action that no one has requested to improve or enhance job results and avoid problems.
Meets deadlines - Displays consistency and success in adhering to deadlines.
Multi-tasking - Demonstrates ability to work on multiple projects simultaneously.
Organization - Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail.
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