Sr Clinical Research Coordinator 2

University of Chicago•Chicago, IL

2d•$75,000 - $90,000

About The Position

The Senior Clinical Research Coordinator 2 independently manages the collection, documentation, analysis, and reporting of clinical research data and contributes to strategic, administrative, operational, and financial decisions affecting research across the University. The role leads research activities and management for the Bionic Breast project and other human-subjects studies, ensuring compliance with institutional, state, and federal requirements. It applies intermediate-to-advanced quantitative, qualitative, and textual analysis skills to studies focused on women’s health, aging, and the health of marginalized populations. The coordinator analyzes findings, writes articles, reports, and manuscripts, and assists with presentations of research results. The position manages complex clinical research projects, including study planning, monitoring, execution, data operations, regulatory submissions, and progress toward scientific milestones. It supervises and trains research staff, students, and trainees, and prepares or evaluates protocols, grant applications, manuscripts, reports, and dissemination materials. The position operates under limited supervision and is wholly or partially funded by contractual grant funding; continued employment depends on receipt of the grant funds and satisfactory performance. The Lindau Laboratory is an interdisciplinary, team-based research laboratory at the University of Chicago. Its research includes preservation and treatment of female sexual function in the context of aging, cancer, and other diseases, as well as social determinants of health, particularly for women and older adults in socioeconomically marginalized communities. The lab conducts observational, interventional, and health services research and collaborates across disciplines and institutions.

Requirements

College or university degree in a related field.
Five to seven years of work experience in a related job discipline.
Strong critical-thinking and problem-solving skills.
Strong analytical skills and proficiency in STATA, R, or equivalent programs.
Qualitative data analysis experience using ATLAS-TI or similar software.
Demonstrated leadership, interpersonal, and relationship-building skills.
Ability to work independently and as part of a team in a fast-paced environment.
Excellent organization and verbal and written communication skills, and ability to work effectively with people from many backgrounds.
Ability to work with sensitive subject matter.

Nice To Haves

Master’s degree in a related field such as health services research, clinical research, public health, or epidemiology.
Five years of relevant research experience.
Knowledge and experience related to women’s sexual health and social drivers of health.
Expertise in investigator-initiated clinical trials, community- and population-based trials and other studies, clinical epidemiology, health services research, and patient-reported outcome measure development.
Experience with successful NIH grant writing and with writing manuscripts, presentations, and human-subjects and regulatory protocols and implementing those protocols.
Expert-level proficiency in Microsoft Word, Excel, PowerPoint, and scientific search engines.

Responsibilities

Perform a significant role in the design, development, and implementation of quantitative and qualitative research studies, including grant writing, survey development, participant recruitment, enrollment, and interviewing.
Manage high-complexity clinical studies, including scientific study planning, monitoring, and execution of investigator-initiated research, and coordinate administrative tasks to meet scientific milestones and deliverables.
Recognize abnormal results and varying conditions or procedures, correct problems, and set up and perform experiments.
Collect, prepare, manage, and analyze data for qualitative and quantitative research.
Prepare and lead presentations and manuscripts, including as first author and presenter, for scientific meetings and peer-reviewed publications.
Conduct and supervise literature searches, synthesis, and citation management while ensuring best practices.
Track data collection progress, identify deviations from projected accrual plans, direct corrective action, and collaborate with the research operations lead to keep collection on budget and on schedule.
Support compliant research conduct and regulatory and administrative activities, including leading development and management of IRB protocols in coordination with peer experts.
Stay current with and manage processes involving IRB, FDA, NIH, HIPAA, CITI, clinicaltrials.gov, and the Florence portal.
Ensure project compliance with applicable policies, procedures, directives, and mandates.
Train and supervise research trainees, students, and staff; ensure trainees meet project milestones and complete their research learning objectives.
Manage the daily administrative and technical activities of a highly complex clinical trial or multiple moderately complex concurrent trials; design and guide internal and external audits and manage external surveys.
Implement Good Clinical Practices and applicable local, state, and federal laws, regulations, policies, and procedures; develop and implement consistent standards and protocols.
Resolve complex data-management and large administrative-dataset analysis problems; independently develop, manage, and report key data and ensure timely data and reporting submissions from multiple investigators.
Serve as a resource for colleagues on clinical research and clinical study fundamentals; prepare and evaluate protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.
Remain accountable for tasks and complex problem-solving on assigned clinical studies and professional work.
Facilitate and participate in daily activities of complex clinical studies, including patient data retrieval, clinical research record documentation, and program audits; coordinate collection of analyzable clinical data and/or samples with a high degree of independence.
Perform other related work as needed.