Clinical Research Operations Manager
Department
BSD NEU - HAARC - Administration
About the Department
Job Summary
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 collection of analyzable clinical research data and/or samples with a high degree of independence.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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Preferred Qualifications
Education:
Advanced degree.
Experience:
Leadership or management experience.
Preferred Competencies
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).
Application Documents
Resume/CV (required)
Cover Letter (required)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
Average salary estimate
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