Northwestern University

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).. Ability to successfully complete the requirements of the Northwestern Memorial Hospital Research Access Program.. Ability to seek certification as a clinical research coordinator.. The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations.

research project coordinator

Department: MED-Pulmonary 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. 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). Specific Responsibilities Technical <ul><li> Leads execution & control of a biomedical &/or social science project or research study. </li><li> Coordinates processing & analysis of data, conduct of experimental tests & procedures </li><li> Develops new &/or revised research methodologies. </li><li> Ensures completion of study activities per protocol including recruitment. </li><li> Ascertains pretreatment & eligibility requirements. </li><li> Obtains informed consent. </li><li> Registers participant with appropriate sponsor. </li><li> Interviews & obtains medical & social histories. </li><li> Collects data from medical records. </li><li> Administers, schedules &/or scores tests. </li></ul>Administration <ul><li> Oversees & manages collection, maintenance, analysis & evaluation of data that will be used in grant submissions, presentations & publications. </li><li> Ensures that information is entered correctly into databases. </li><li> Coordinates between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions. </li><li> Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner. </li></ul>Finance <ul><li> Manages lab/study budget & inventory including purchasing of supplies & services ensuring that they are necessary, reasonable & project related. </li><li> Orders & maintains inventory of study supplies. </li></ul>Supervision <ul><li> Trains, directs, assigns duties to & supervises research staff, students, residents &/or fellows. </li><li> Acts as a mentor in regard to education of junior coordinators. </li><li> Performs other duties as assigned. </li></ul>Minimum Qualifications: (Education, experience, and any other certifications or clearances) <ul><li> 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 </li><li> 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. </li><li> Supervisory or project management experience required. </li><li> Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years </li></ul>Minimum Competencies: (Skills, knowledge, and abilities.) <ul><li> Ability to successfully complete the requirements of the Northwestern Memorial Hospital Research Access Program. </li></ul>Preferred Qualifications: (Education and experience) <ul><li> Prior working experience with IRB preparation and submission. </li><li> Prior working experience with REDCap. </li></ul>Preferred Competencies: (Skills, knowledge, and abilities) <ul><li> Skill/ability in use of standard computer programs (Microsoft Excel, Outlook, and Word) and navigation of the internet. </li><li> Ability to seek certification as a clinical research coordinator. </li><li> Action oriented - Willing or likely to take practical action to deal with a problem or situation. </li><li> Coachability - Receptive to feedback, willing to learn, embracing continuous improvement. </li><li> Collaboration - Facilitates open and effective communication, cooperation and teamwork within and outside of one's own team. </li><li> Collegiality - Helpful, respectful, approachable; builds strong working relationships and a positive work environment. </li><li> 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. </li><li> Meets deadlines - Displays consistency and success in adhering to deadlines. </li><li> Multi-tasking - Demonstrates ability to work on multiple projects simultaneously. </li><li> Organization - Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail. </li></ul> Target hiring range for this position will be between $49,850 to $70,419 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 At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html tolearn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you’re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more. Northwestern strongly recommends COVID-19 vaccinations and boosters for people who can obtain them as a critical tool for minimizing severe illness. More information can be found on the COVID-19 and Campus Updates webpage. The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today. 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. Click for information on EEO is the Law.

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