The Clinical Research Coordinator manages daily operations of a biomedical &/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors & other external project stakeholders. This role monitors study performance, analyzes & review results, reviews technical operations ensuring that all processes, protocols & procedures are quality controlled & functioning up to standards. This position may co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants. The Clinical Research Coordinator 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 position is for the research study therapist role on a clinical research intervention trial of smoking cessation and depression. The position requires a therapist, counselor, or clinical social worker to administer the study’s protocol for smoking cessation, working with individuals with depression. The intervention involves two different behavioral therapy protocols, administering psychiatric diagnostic interviews, and addressing medication adherence.
Manages and ensures completion of study activities per protocol.Collaborating with staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.
Manages conduct of experimental tests & procedures.Closely monitors & documents patient's adverse events; partners with staff in modifying dosages, tests & treatment schedule.
Conducts smoking cessation therapy sessions, in-person and by phone, per study protocol. There are two pre-quit visits, one target quit day visit and six booster sessions (each 1-hour in duration).
Conducts psychiatric diagnostic interviews to determine participant eligibility.Assists with other baseline intake procedures including vitals and height/weight, paper and pencil assessments, and obtaining participants’ smoking verification.
Introduces the study medication to participants and provides instruction on use during the pre-quit session. Distributes pill packs at appropriate in-person sessions. Manages any issues regarding medication adherence with participants as necessary.
Monitors/assesses potential study medication side effects for all assigned participants and works with PI and study physician to manage them as necessary. Writes and submits any adverse event reports to the IRB and study sponsors as necessary and defined within the intervention Safety Monitoring and Reporting Protocol.
Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives.Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
Manages day-to-day project operational functions; implements existing policy & ensures the effective, compliant, & efficient completion of daily administrative operations.
Ensures appropriate and timely compliance with associated local, state, & federal regulatory guidelines, requirements, & laws; & research protocols.
Performs other duties as assigned.
A bachelor's degree in a social or health science + 2 years’ experience; or 4 years practical research study or related experience; or a master's degree in a social or health science + 1 year experience is 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.)
Communicates effectively one-to-one and in small groups.
Plans, organizes, and schedules in an efficient, productive manner.
Proficiency with Microsoft Office software, including Access.
Strong clinical interviewing experience.
Strong communication skills.
Strong interpersonal skills.
Ability to have flexible hours to accommodate participants.
Preferred Qualifications: (Education and experience)
A master’s degree in clinical psychology, counseling psychology, or clinical social work, or related field or the equivalent combination of education, training and experience from which comparable skills can be acquired.
Previous training in cognitive or behavioral therapy; previous experience conducting psychological assessments and clinical diagnostic interviews.
Smoking cessation treatment certification.
Previous work experience in a clinical research environment.
Preferred Competencies: (Skills, knowledge, and abilities)
Knowledge of smoking cessation and depression treatment techniques
Knowledge or experience working with individuals with major depressive disorder
Knowledge of varenicline and other FDA-approved smoking cessation medications
Excellent, effective time management skills
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.
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 highl...y collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.