Clinical Research Coordinator

Department: MED-Psych & Behavioral Science
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. 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).

Please note: Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.

Specific Responsibilities:

Technical

• Lead execution & oversight of a biomedical &/or social science project or clinical research study including participant recruitment and retention.
• Manage and ensure completion of study activities per protocol. Collaborating with research staff and Principal Investigator (PI) ascertain pretreatment & eligibility requirements; interview participants & obtain social & medical histories; based on results determines & registers participants; oversee subject enrollment and completes informed consent; plans and carries out study visits, including data collection and entry of data into electronic database.
• Administer tests and/or questionnaires following study protocols.
• Complete basic clinical procedures such as drawing blood and obtaining blood pressure. Closely monitor & document patient's adverse events and confer with investigators regarding reports of events or oversight agencies.
• Extract and analyze data from medical charts.
• Do site visits within Chicago area as needed.
• Train and oversee work of junior clinical research staff.
• Prepare for or participate in quality assurance audits or monitoring visits by study sponsors, federal agencies or specially designated review groups.

Data

• Manage project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partner with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
• Provide consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.

Administration

• Manage project, collaborating and partnering with all internal/external staff including sponsoring agencies, organizations &/or other research &/or educational institutions to ensure project objectives and timelines are attained. Advise project staff on enhancements and changes to processes, practices, and procedures to ensure compliance with protocols and to increase effectiveness and efficiency of project.
• Manage day-to-day project operational & business functions; implements existing policy & ensures the effective, compliant, & efficient completion of daily administrative operations.
• Maintain required records of study activity including case report forms, study participant charts or regulatory forms.
• Aid in negotiation of contracts and budgets, processes invoices and payments.
• Ensure appropriate and timely compliance with associated local, state, & federal regulatory guidelines, requirements, & laws; & research protocols.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• 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.

• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years

Minimum Competencies: (Skills, knowledge, and abilities.)

• Working knowledge of Good Clinical Practices (GCP) and other state and federal regulations and laws.

• Active listening and coordination.

• Ability to coordinate 3 or more clinical trials with minimal supervision.

Preferred Qualifications:

• 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

• MA/MS degree and 2 years of experience in clinical research coordination

• 3 years of experience in clinical research

Preferred Competencies: (Skills, knowledge, and abilities)

• Clinical skills such as phlebotomy, conducting ECG, taking vitals, and solid medical/clinical knowledge

Target hiring range for this position will be between $51,346 to $72,532 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 to learn 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 University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

#LI-JP1