Clinical Research Associate

Department: MED-Surgery
Salary/Grade: RES/

Job Summary:

The following describes the role of the Clinical Trials Operations Manager, Clinical Research Associate. Manages daily operations of clinical trial research studies 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 coordinator 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: Occasional weekends and evenings as requested and with some possible travel, as required.

Specific Responsibilities:

Technical

• Leads execution & control of clinical trial research projects or studies.
• Manages and ensures completion of study activities per protocol in collaboration with PI and Research Student Coordinators. Oversees completion of study activities, in collaboration with Research Study Coordinator, including study design and implementation; data collection tool development; data quality assessment and ongoing monitoring; regulatory reporting; statistical analysis; interpretation of results and manuscript writing.
• Manages conduct of experimental tests & procedures. Ensure patient adverse events are closely monitored & documented; ensure Coordinator/PI modify dosages, tests & treatment schedule.

Data

• Manages collection of 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.

Administration

• Manages 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. Advises project staff on enhancements and changes to processes, practices, and procedures to ensure compliance with protocols and to increase effectiveness and efficiency of project.
• Manages day-to-day core operational & business 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.

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
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
• Knowledge of biology or medicine gained through education or prior work experience preferred

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

• Ability to successfully complete the requirements of the Northwestern Memorial Hospital Research Access Program.
• Coachability - Receptive to feedback, willing to learn, embracing continuous improvement.
• Collaboration - Facilitates open and effective communication, cooperation and teamwork within and outside of one's own team.
• Collegiality - Helpful, respectful, approachable; builds strong working relationships and a positive work environment.
• Multi-tasking - Demonstrates ability to work on multiple projects simultaneously.
• Critical & analytical thinking - Uses logic and reason to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
• Ability to successfully navigate and use enterprise systems/databases, Microsoft Office software (Excel, Outlook, PowerPoint, & Word), and Internet browsers.

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 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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