Clinical Research Data Manager

Department
 

BSD MED - Pulmonary - Clinical Research Staff

About the Department
 

The University of Chicago’s Respiratory Clinical Research team assists Principal Investigators in conducting drug trials, device trials, observational studies, databases, and biorepositories for a range of pulmonary diseases. The clinical research core provides support to nine Principal Investigators, who conduct both industry sponsored and grant funded projects (federal and foundation).

Job Summary
 

The Clinical Research Data Manager will perform a variety of data management duties of a complex and technical nature in support of clinical research studies conducted by principal investigators (PIs) for the clinical research program to ensure adherence to protocols and quality of information received.

Responsibilities

• Maintains a close, collaborative working relationship with the PIs to effectively manage research studies, with the department, with the administrative team, and the department staff.

• Builds and maintains effective relationships with key study personnel, clinical resources and colleagues throughout.

• Responsible for all data management aspects of clinical studies and efficiently performs all data management activities within an assigned study or studies.

• Provides data management expertise to the team in identifying opportunities for improvement.

• Ensures validity of research results through timely, accurate, and complete data submission, query resolution, and reporting of deviations.

• Demonstrates proficiency in the use of clinical and research-related computer programs.

• Ensures that relevant data from the source document are abstracted and recorded in the clinical trial case report forms and that every data point can be verified within the source document.

• Utilizes analytical thinking, attention to detail, and problem-solving skills.

• Facilitates communication between the site and study sponsor, CRO, and/or regulators and exhibits teamwork skills necessary for managing the data collection and reporting process.

• Assists with various professional, organizational, and operational tasks under direct supervision.

• Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• 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 < 2 years of work experience in a related job discipline.

---
Certifications:

---

Preferred Qualifications

Education:

• Bachelors degree.

Experience:

• Research or relevant experience.

• Well versed in medical and/or clinical trial terminology.

• Background in relevant scientific field.

Technical Skills or Knowledge:

• Proficient in Microsoft Word, Excel and Adobe Acrobat.

Preferred Competencies

• Demonstrated ability to abstract subject data from medical record/source documentation and enter into care report forms and/or databases.

• Background generating and resolving queries and/or monitoring data.

• Handle competing demands with diplomacy and enthusiasm.

• Perform research data management with minimal supervision.

• Strong data management skills and attention to detail.

• Work collaboratively and with divisional research offices.

• Maintain a high degree of confidentiality with clinical data and client's proprietary data.

• Adaptability to changing working situations and work assignments.

• Work independently and as part of a team.

• Analytical skills.

• Excellent multi-tasking skills.

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
 

Individual Contributor

FLSA Status
 

Exempt

Pay Frequency
 

Monthly

Scheduled Weekly Hours
 

40

Benefits Eligible
 

Yes

Drug Test Required
 

No

Health Screen Required
 

No

Motor Vehicle Record Inquiry Required
 

No

Posting Statement
 

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, 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.

 

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.

 

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.