Clinical Research Manager - Hematology and Oncology

uchicago; Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

The University of Chicago is seeking a Clinical Research Manager in the BSD MED Hematology and Oncology – Clinical Research group. You will oversee multiple trial types, coordinate with sites, the Clinical Trials Office, and sponsors to ensure protocol compliance and timely study conduct.

Responsibilities include day-to-day project oversight, data management, monitoring, budgeting, and training of staff. A strong background in clinical research leadership and regulatory knowledge is required.

Qualifications

• College or university degree in a related field.
• 7+ years of work experience in a related job discipline.
• Experience with clinical trials management and regulatory requirements.

Responsibilities

• Directs a program or research office.
• Oversees data collection, monitoring, and analysis for multiple trials.
• Coordinates with sites, the Clinical Trials Office, and sponsors to ensure protocol compliance.
• Prepares grant/funding applications and manages program budgets.
• Supervises researchers and support staff.
• Ensures regulatory compliance with IRB and other authorities.

Education

Bachelor's degree or higher in related field

7+ years of experience in clinical research

GCP knowledge

Job description

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)

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

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.

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