Assistant Manager, Clinical Research

Department
 

BSD SUR - Research Services: Clinical Research

About the Department
 

Operating since 1927 on a strong foundation of multidisciplinary clinical and academic excellence, the University of Chicago Department of Surgery's mission is to meet the most challenging and complex health problems on both a local and global scale.

Many of our faculty members are known for their contributions to the advancement of groundbreaking surgical procedures and techniques, including minimally invasive surgery. In addition to our department's clinical work, our scientists pursue a diverse range of basic, translational, and clinical research projects, including studies on the gut microbiome, tissue bioengineering, stem cell research, cancer, and immunotolerance.

This ongoing work and achievement would not be possible without the cohesive effort and commitment of the faculty and staff. We are looking for high energy, collaborative individuals who share our commitment to improving the health of patients in the community and beyond.

Job Summary
 

The Assistant Clinical Research Manager independently manages clinical research protocols such as industry sponsored and pharmaceutical. Serves as a liaison between faculty, section support staff, and sponsoring agents. Provides guidance to faculty for study start up documents (schema/schema review memo) needed prior to negotiations. Works directly with the faculty and research staff to seek new avenues with pharmaceutical companies.

Responsibilities

• Works with the Department of Surgery faculty to complete start-up activities and documents as well as sponsor start-up visits.

• Assists in the orientation, onboarding and training of new and current Surgery Research Services (SRS) coordinators.

• Engages in team development through coaching and mentorship.

• Supervises coordinator work for maintaining data integrity.

• Assists faculty in navigating industry sponsored start-ups.

• Assists Associate Director in internal audits and provides audit reports for ethics, enrollment, and data integrity.

• Prioritizes and manages multiple projects simultaneously and follows through on issues in a timely manner.

• Completes clinical coordinator role for high complex clinical trials.

• Manages own portfolio of clinical trials as lead coordinator.

• Assists Associate Director with developing and managing departmental communications.

• Serves as main point of contact with Sponsor during start-up activities for industry sponsored clinical trials.

• Independently trains clinical research coordinators on the day to day tasks required to conduct and execute a research study and the Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study.

• Provides backup to clinical research coordinators.

• Assists coordinators in day to day activities to execute their clinical trials.

• Works with hospital facilities to execute clinical trials.

• Assists Associate Director with industry sponsored clinical trials as needed.

• Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.

• Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.

• 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 5-7 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Experience:

• Prior clinical research experience in an academic medical center.

Preferred Competencies

• Ability to train others and provide constructive feedback.

• Excellent oral and written communication skills.

• Strong project management skills, strategic problem solving and attention to detail.

• Ability to understand complex protocols to assist with billing and budget discussions.

• Motivated and detail-oriented.

• Presentation skills.

• Strong interpersonal skills.

• Commitment