Biological Sciences Division at the University of Chicago ยท 2 months ago
Clinical Research Operations Manager
Chicago, IL
Full-time
Onsite
Mid, Senior Level
$75K/yr - $90K/yr
5+ years expThe Biological Sciences Division at the University of Chicago is focused on neurological research and care. The Clinical Research Operations Manager is responsible for overseeing daily operations of clinical research studies, ensuring compliance with regulatory requirements, and managing study personnel and resources.
Higher Education
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 collection of analyzable clinical research data and/or samples with a high degree of independence
Performs other related work as needed
Qualification
Required
Minimum requirements include a college or university degree in related field
Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline
Resume/CV (required)
Cover Letter (required)
Preferred
Advanced degree
Leadership or management experience
Excellent communication skills (verbal and written)
Excellent interpersonal skills
Excellent time management and ability to prioritize work assignments
Excellent attention to detail
Ability to comprehend technical documents
Ability to develop and manage interpersonal relationships
Ability to exercise absolute discretion regarding confidential matters
Ability to give directions
Ability to handle sensitive matters with tact and discretion
Ability to handle stressful situations
Ability to perform multiple tasks simultaneously
Ability to train or teach others
Demonstrated knowledge of Good Clinical Practices (GCP)
Benefits
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.
Company
Biological Sciences Division at the University of Chicago
As part of the University of Chicago, the Biological Sciences Division (BSD) pursues globally impactful solutions to seemingly unsolvable challenges.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase