Northwestern University Research Project Coordinator in Chicago, Illinois
The Research Project 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. 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).
- 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 participant with appropriate sponsor.
- Interviews & obtains medical & social histories.
- Collects data from medical records.
- Administers, schedules &/or scores tests.
- Collects physical measurements such as blood pressure, heart rate, height and weight from subjects.
- Performs blood draws as necessary for study procedures.
- Collaborates with CRO as well as sponsor for successful completion of study procedures.
- Maintains ISF before, during and after study completion.
- 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.
- Responsible for Regulatory documents submission to either Sponsor Company and/or IRB as necessary.
- 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.
- Tracks subject payments as well as invoices from NMH services.
- Trains, directs, assigns duties to & supervises research staff, students, residents &/or fellows.
- Acts as a mentor in regard to education of junior coordinators.
- Delegates certain responsibilities to Research Assistants such as X-ray appointments or delivering blood samples to the CRU for lab processing.
- 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 Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
- Ability to provide informed consent.
- Ability to collect all required procedures per protocol and enter data into data entry system.
- Clear understanding of federal and local Biomedical Clinical Research Regulations.
- Experience working with clinical trial subjects.
- Experience conducting clinical research studies.
- Certification as a clinical research coordinator.
Preferred Competencies: (Skills, knowledge, and abilities)
- Phlebotomy training.
- Possesses good communication skills to be able to communicate effectively between the site, sponsor, and CRO, as well as understanding of teamwork skills necessary for conducting a clinical trial.
- Experience in clinical setting, making clinical judgements as necessary.
- Experience using REDCap.
- Self-motivated learner.
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. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Job ID: 33751
Full/Part Time: Full-Time
Location: Chicago, Illinois
Job Title: Research Project Coordinator