Clinical Research Manager - Hematology and Oncology

Posted 13 Days Ago
Be an Early Applicant
Chicago, IL, USA
In-Office
90K-130K Annually
Senior level
Edtech
The Role
Manage and oversee hematology/oncology clinical research programs, including project and data management, protocol compliance, IRB submissions, budgeting, staff supervision, monitoring/auditing, grant applications, and coordination with sponsors and sites to ensure regulatory and ethical conduct of trials.
Summary Generated by Built In

Department

BSD MED - Hematology and Oncology - Clinical Research - Solid Tumor


About the Department

The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.


Job Summary

The Clinical Research Manager will provide project management, data management and clinical monitoring support for multiple types of trials, including sponsored, grant funded, multi-site, and/or investigator-initiated trials, in the Section of Hematology/Oncology in the Department of Medicine. The Clinical Research Manager will act as a liaison between clinical sites, the Clinical Trials Office and sponsors/agencies to ensure that clinical trials are conducted in compliance with the protocol and applicable institutional and regulatory guidelines. Provide day to day project oversight and management to the Clinical Research Coordinators.

Responsibilities

  • Directs a program or research office.
  • Conducts research in area of expertise.
  • Collaborates with other researchers on long-range plans for research projects.
  • Oversees the development of research projects.
  • Ensures research projects progress according to plan.
  • Investigates, modifies and applies new procedures, techniques, or applications of technology.
  • Establishes goals and operating procedures, practices, and guidelines.
  • Establishes, monitors, and controls project budgets.
  • In collaboration with research faculty and personnel, participates as a skilled individual contributor and/or researcher.
  • Prepares grant/funding applications.
  • Manages financial, personnel, planning, compliance and other administrative aspects of research project(s).
  • Oversees activities related to data collection and analysis.
  • Coordinates the conduct of the study from screening to completion, including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
  • Protects patients and data confidentiality by ensuring security of research data and personal health information.
  • Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
  • Understands the IRB submission and review process, and when and how to apply for IRB review including facilitation of study initiation through meticulous and timely preparation of IRB submissions.
  • Understands the federal research regulations and identifies the federal research organizations’ role in regulating human research participation.
  • Identifies and explains the responsibilities of principal investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
  • Supervises both researchers and research support staff.
  • Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
  • Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.
  • Performs other related work as needed.


Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.


Work Experience:

Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.


Certifications:

---

Preferred Qualifications

Education:

  • Master's degree.

Experience:

  • Supervisory skills.
  • Background in a leadership role.

Certifications:

  • Research certification, such as Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP.

Technical Skills or Knowledge:

  • Proficient in monitoring and auditing clinical research trials for compliance/billing accuracy, such as site monitoring, quality assurance, and creating monitoring plans.
  • Working knowledge of managing research projects.
  • Develop research program and work strategically with principal investigator(s).
  • Lead robust operational and financial analysis of study(ies) and/or program performance.
  • Read and understand clinical trials protocols.
  • Knowledge of regulatory policies and procedures.
  • Knowledge of grant and contract administration.
  • Familiarity with medical and scientific terminology.
  • Demonstrated knowledge of Good Clinical Practices (GCP).

Preferred Competencies

  • Develop a program and a team.
  • Excellent time management skills and work independently.
  • Strong analytical skills.
  • Identify funding sources.

Application Documents

  • Resume/CV (required)
  • Cover Letter (required)

The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions.
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.


Job Family

Research


Role Impact

People Manager


Scheduled Weekly Hours

37.5


Drug Test Required

Yes


Health Screen Required

Yes


Motor Vehicle Record Inquiry Required

No


Pay Rate Type

Salary


FLSA Status

Exempt


Pay Range

$90,000.00 - $130,000.00

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

Yes

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.

Skills Required

  • College or university degree in related field
  • 7+ years of work experience in a related job discipline
  • Master's degree
  • Supervisory skills / leadership experience
  • Research certification (e.g., Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP)
  • Proficiency in monitoring and auditing clinical research trials for compliance and billing accuracy
  • Working knowledge of managing research projects and developing research programs
  • Demonstrated knowledge of Good Clinical Practices (GCP)
  • Knowledge of regulatory policies and procedures, IRB submission processes, and federal research regulations
  • Knowledge of grant and contract administration
  • Familiarity with medical and scientific terminology
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The Company
Chicago, IL
Year Founded: 1890

What We Do

The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to rigorous inquiry and intellectual freedom draws pathbreaking scholars to our global campuses, where field-defining ideas are born that challenge and change the world. The University of Chicago has its main campus on Chicago's South Side and seven international campuses and centers throughout the world. Students can choose from 53 majors and 47 minors in the undergraduate College, with four divisions and seven professional schools for graduate study.

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