Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant 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).
Recruits and consents patients for Urology studies. Responsible for database management and maintenance of confidentiality. Completes periodic review data for studies for the Institutional Review Boards. Collects patient specimen from operating rooms, pathology department and the Urology clinic. Updates databases, authors IRB protocols and consents, and maintain other institutional regulatory paperwork. Ensures the submission and maintenance of accurate, timely, complete and reliable data and reports by implementing data management and quality assurance procedures May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants and study documents.
Participates in the planning & conduct of research study including participant recruitment and retention.
Obtains informed consent.
Administers tests &/or questionnaires to study participants.
Completes basic clinical procedures such as drawing blood & obtaining blood pressure.
Collects tissue and other human specimens for laboratory processing.
Ensures completion of study activities per protocol including recruitment.
Collects, records, reviews & summarizes research data.
Maintain study databases with participant data.
Prepares reports for investigators and sponsors on recruitment status and other pertinent study data.
Write protocols and informed consent documents.
Assist with IRB and federal audits of research studies.
Prepare and submit new protocols, continuing review proposals and modifications for IRB review.
Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed and maintained in a timely manner.
Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols.
Maintains detailed records of results which may include collecting, extracting & entering data; &/or preparing basic charts & graphs.
Performs scientific literature searches in support of research.
Assists with planning of the annual Urology research retreat.
Facilitate approval of data usage and material transfer agreements.
Process and track payments for research participants per study protocol.
May order lab supplies.
May provide work direction &/or train others involved in research to ensure compliance with University and federal policies.
May act 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 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.
Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Demonstrated knowledge of human subject research policies and training in biomedical research methodology.
Demonstrated familiarity with medical and research terminology.
Demonstrated knowledge of federal and state regulations governing the participation of human subjects.
2-3 years practical research study or related experience
Past experience supporting researchers or physicians
Preferred Competencies: (Skills, knowledge, and abilities)
Scientific writing skills, including the ability to write and decipher information from complex documents and websites
Strong attention to detail
Clear communication skills and the ability to tailor communication to different audiences
Ability to work with a broad range of constituencies and direct action to superiors, including senior administrators, faculty, fellows and residents
Ability to work efficiently and with multiple tasks with various deadlines.
Ability to take initiative for projects.
Ability to think creatively to resolve problems.
Ability to work effectively in an environment in which parameters may change daily and to adjust behavior to meet the needs of different people and situations
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.
Internal Number: 37539
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.