Clinical Research Manager

Details

Posted: 13-May-23

Location: Chicago, Illinois

Type: Full-time

Salary: Open

Categories:

Research - Laboratory/Non-Laboratory
Staff/Administrative

Internal Number: JR21785

Location: Chicago, IL

Job Description:

Research Conduct/Study Management:

• Responsible for the direction of a program or research office.

• Conduct research in area of expertise.

• Collaborate with other researchers on long-range plans for research projects.

• Oversee the development of research projects.

• Ensure research projects progress according to plan.

• Investigate, modify and apply new procedures, techniques or applications of technology.

• Establish goals and operating procedures, practices, and guidelines.

• Establish, monitor, and control project budgets.

• In collaboration with research faculty and personnel, participate as skilled individual contributor and/or researcher.

• Prepare grant/funding applications.

• Manage financial, personnel, planning, compliance and other administrative aspects of research project(s).

Data Management:

• Oversee activities related to data collection and analysis.

• Coordinate the conduct of the study from screening through to completion including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.

• Protect patients and data confidentiality by ensuring security of research data and personal health information.

Regulatory:

• Ensure compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.

• Understand 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.

• Understand the federal research regulations and identify the federal research organizationsâ™ role in regulating human research participation.

• Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

Supervision:

• Supervise 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.

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  Performs other related work as needed.

  
  

Preferred Qualifications

Education:

• Master's degree.

Experience:

• Proficient in monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans).

• Supervisory skills.

• Working knowledge of managing research projects.

• Background in a leadership role.

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)

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 the Applicant Inquiry Form.

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: 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.

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