Sr Clinical Research Coordinator 2

University of Chicago•Chicago, IL

About The Position

The Senior Clinical Research Coordinator 2 independently manages the collection, documentation, analysis, and reporting of clinical research data. The role leads research activities and manages the Bionic Breast project and other human-subjects studies, while contributing to strategic, administrative, operational, and financial decisions affecting clinical research at the University. It ensures research complies with institutional, state, and federal requirements and uses intermediate-to-advanced quantitative, qualitative, and textual analysis skills to support studies in women’s health, aging, and the health of marginalized populations. The position performs project management for complex clinical studies, supports study design and implementation, manages regulatory and administrative activities, and contributes to grant writing, publications, presentations, and dissemination. It trains and supervises research trainees, students, and staff and works independently under limited supervision. This is an at-will role wholly or partially funded by contractual grant funding; continued employment depends on continued receipt of the funding and satisfactory job performance.

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 skills using ATLAS-TI or similar software.
Demonstrated leadership, interpersonal, and relationship-building skills.
Ability to work independently and collaboratively in a fast-paced environment.
Excellent organizational, verbal, and written communication skills.
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, clinical epidemiology, health services research, or patient-reported outcome measure development.
Experience with successful NIH grant writing, manuscript and presentation writing, and writing and implementing human-subjects and regulatory protocols.
Expert-level proficiency in Microsoft Word, Excel, PowerPoint, and scientific search engines.

Responsibilities

Contribute significantly to 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 planning, monitoring, execution of investigator-initiated research, and administrative work needed to meet milestones and deliverables.
Recognize abnormal results and changing conditions or procedures, correct problems, and set up and perform experiments.
Analyze the meaning, significance, causes, and effects of research findings.
Collect, prepare, manage, and analyze data for quantitative and qualitative studies.
Prepare and lead presentations and manuscripts, including as first author and presenter, for scientific meetings and peer-reviewed publication.
Conduct and supervise literature searches, synthesis, and citation management, ensuring best practices.
Track data-collection progress, identify deviations from projected accrual plans, direct corrective actions, and collaborate with the research operations lead to keep data collection on schedule and within budget.
Lead development and management of IRB protocols and support compliant regulatory and administrative activities in collaboration with subject-matter experts.
Manage and stay current with IRB, FDA, NIH, HIPAA, CITI, clinicaltrials.gov, and Florence portal processes.
Ensure project compliance with applicable policies, procedures, directives, and mandates.
Train and supervise research trainees, students, and staff; monitor project milestones and completion of learning objectives.
Manage daily administrative and technical activities for 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 problems and analyze large administrative datasets.
Develop, manage, and report key data independently, ensuring timely data and reporting submissions from multiple investigators.
Serve as a resource for colleagues and clinical research staff on clinical research and clinical-study practices.
Prepare and evaluate protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.
Coordinate complex clinical studies, retrieve patient data, document clinical research records, and participate in program audits.
Coordinate collection of analyzable clinical research data and/or samples with a high degree of independence.
Perform other related work as needed.