Clinical Research Operations Manager

Department

BSD NEU - HAARC - Administration

About the Department

The Department of Neurology at The University of Chicago Medical Center has a great history and tradition, having made significant contributions to neurological training, clinical care, and the basic understanding of neurological disease. The Healthy Aging & Alzheimer's Research Care (HAARC) Center, is a multidisciplinary center at the University of Chicago focused on implementing research on aging, Alzheimer’s and related dementia research focused on optimizing knowledge, care, interventions, and quality of life. This at-will position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.

Job Summary

The Clinical Research Operations Manager is responsible for overseeing the daily operations of clinical research studies conducted at the Healthy Aging & Alzheimer’s Research Care (HAARC) Center, ensuring compliance with regulatory requirements, and managing study personnel and resources. This role involves coordinating research activities, monitoring study progress, ensuring data integrity, and fostering collaboration among investigators, sponsors, and research staff. The Clinical Research Operations Manager analyzes possible solutions using standard procedures, writes articles, reports and manuscripts and assists in drafting presentations on research findings.

It will include oversight of IRB, clinical operations, grant reporting/management, logistics including recruitment and retention of participants from the beginning to the end of a study as well as management of research staff.

Responsibilities

• Oversee Center Clinical Research Portfolio across the lifecycle for each protocol from feasibility, startup, recruitment, day-to-day conduct, follow up through study close out.

• Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedures developed by the Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).

• Develop and implement standard operating procedures (SOPs) to optimize research workflows in accordance with study sponsor, primary investigator, and regulatory specifications.

• Oversee the conduct of clinical research, regulatory compliance, and IRB filings for all projects in the departmental portfolio. This includes preparing and maintaining protocol submissions and revisions.

• Oversee the collection and processing of research specimens to the appropriate laboratory according to established aseptic techniques and SOPs.

• Plans and coordinates research participant schedules for study procedures and study follow-up visits according to study protocol and SOPs.

• Ensure research staff educate research participants about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.

• Supports data collection and analytical needs of research projects. Conducts literature reviews and helps write reports and manuscripts. Ensures project compliance with different policies, procedures, directives, and mandates.

• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), and study related communication.

• Organizes and leads local operations meetings and site visits from sponsors, federal agencies, or specially designated review groups.

• Oversee hiring and training of new clinical research staff.

• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• May co-author scientific papers for presentation & publication and assist with writing, submission & administration of grants.

• Accountable for all tasks in complex clinical studies.

• Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses in-depth knowledge of clinical studies to coordinate the