Assistant Director, Clinical Research Data Management

Department
 

BSD MED - Section Administrator: Hematology and Oncology - Clinical Research Staff

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 Assistant Director supports the Director of Clinical Research Operations and Director of the Clinical Trial Support Office in developing strategy, training, and establishing standards and best practices for data management and data quality for our oncology clinical trial portfolio. The trial portfolios includes industry studies, multi-site investigator-initiated studies, single-site investigator-initiated studies, and National Clinical Trial Network (NCTN) studies.
This position will be responsible for ensuring Cancer Center wide compliance with our local Institutional Review Board (IRB), National Cancer Institute (NCI) guidelines, Good Clinical Practice (GCP) and FDA Regulations. Additionally, this position will oversee the recruitment, placement, and management of the clinical research data managers assigned to or oncology clinical trial portfolio and ensure that all staff are entering data and answering queries accurately and in a timely fashion. The position will work closely with Director of Clinical Operations on various project and initiatives in order to improve overall clinical research operations. The Assistant Director will collaborate and liaise with leadership within the Cancer Center, University Research Administration (URA), Office of Clinical Research (OCR), and Institutional Review Board (IRB) as well as Program Directors, Clinical Research Managers, faculty and other key constituents throughout the University and network as needed.
The position is a 60% effort/reporting to the Section of Hematology/Oncology and 40% effort/reporting to University of Chicago Comprehensive Cancer Center (UCCCC).

Responsibilities

• Define strategy and create a roadmap on how to leverage key systems such as EPIC, REDCap, Velos, & Florence eRegulatory for effective data management; collaborate with partner teams on strategy development and implementation.

• Supervise, support and train data management staff; ensure contractual obligations regarding data entry are met.

• In collaboration with faculty and Clinical Research Managers, review and manage trial priorities from a data management perspective and align data management staff based on disease, workload, sponsor databases, trial type, or therapeutic drugs.

• Oversee the development and maintenance of relevant data management Standard Operating Procedures (SOPs) and instructions related to data management activities for all trial types to ensure that data is submitted on time and according to quality standards and study requirements.

• Define and oversee on-site and remote monitoring visit policy and procedures as well as ensure the data management team is prepared for the visit and action items noted in the monitoring visit follow-up letter are addressed accurately and promptly.

• Ensure monitoring visits, audits and inspections are scheduled and executed successfully; assists with management of monitor and sponsor relationships.

• Liaise with Quality Research Manager and internal monitor on creating any required corrective action and preventative action plans as well as ensure all investigator initialed trials and NCTN trials are meeting required NCI data entry and query resolution timelines.

• Work with the Clinical Trials Financial Group (CTFG) to ensure sponsors are appropriately invoiced for monitoring and auditing activities and ensure data management needs are budgeted correctly.

• Serve as subject matter expert on data management best practices and industry trends.

• 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.

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  Performs other related work as needed.

  
  

Minimum Qualifications
 

Education:

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

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Work Experience:

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

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Certifications:

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Preferred Qualifications

Education:

• Master's degree.

Experience:

• Clinical research experience preferably with oncology.

• Supervisory skills.

• Working knowledge managing research projects.

Licenses and Certifications:

• Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP).

Preferred Competencies

• Develop a program and a team.

• Excellent time management skills and ability to work independently.

• 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.

• Strong analytical skills.

• Knowledge of grant and contract administration.

• Familiarity with medical and scientific terminology.

• Demonstrated knowledge of Good Clinical Practices (GCP).

• Identify funding sources.

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
 

Research

Role Impact
 

People Manager

FLSA Status
 

Exempt

Pay Frequency
 

Monthly

Scheduled Weekly Hours
 

37.5

Benefits Eligible
 

Yes

Drug Test Required
 

Yes

Health Screen Required
 

Yes

Motor Vehicle Record Inquiry Required
 

No

Posting Statement
 

Employees must comply with the University’s COVID-19 vaccination requirements. More information about the requirements can be found on the University of Chicago Vaccination GoForward .
The University of Chicago is an Affirmative Action/ Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

 

Staff 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.

 

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

 

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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