Job Description:

• Coordination and management quality control for observational and interventional, including both clinic and community-based studies, within the Institute for Population and Precision Health.

• This may include multi-institutional and some international studies, many of which are federally funded or funded by pharmaceutical sponsors.

• This may include oversight of the collection of clinical data, survey data, environmental data, and associated samples and biospecimens. 

• Coordination; Institutional Review Board (IRB) preparation; development of data collection instruments; assurance of implementation accuracy and study staff compliance; and continuous reporting on milestones, success, and challenges to study leadership.

• Assists with subject engagement, screening, recruitment, consent, data and specimen collection, and subject follow-up and retention activities.

• Monitors study participants, schedule, and conducts study-related procedures (eg. interviews, phlebotomies, and follow-ups) and establish data quality control checks).

• Works with the Scientific Directors and Research Manager in the planning, development, and evaluation of research.

• Coordination of data acquisition, entry, QC, and query response.

• Assists in the development of new projects and preparation of study reports, and manuscripts for publication.

• Assists in the preparation of presentations, media and curricular materials relating to research.

• Submission of adverse event reporting to sponsor.

• Maintenance of investigator site files according to Good Clinical Practices (GCP) and sponsor guidelines.

• Collection and shipping of biospecimens.

• Assist to oversee the adherence of workflows to clinical trial protocol and GCP.

• Analyzes, facilitates, and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.

• Prepares program conference lists for multidisciplinary conferences and workshops. Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.

• Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.

• Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.

• Performs other related work as needed.

Preferred Qualifications

 

Education:

•  Masterâ™s degree in public health, epidemiology or related field.

 

Experience:

• Minimum 2-5 years of experience in the coordination and or conduction of pharmaceutical clinical trials.

• Good working knowledge of ICH GCP and FDA Code of Federal Regulations.

• Good working knowledge of regulatory and compliance standards of clinical research.

•  Supervisory experience strongly preferred.

 

Preferred Competencies

• Ability to train others.

• Knowledge in relevant scientific field.

• Knowledge of research techniques of methods.

• Knowledge of regulatory policies and procedures.

• Excellent problem problem-solving skills and analytic skills.

• Attention to detail and excellent organizational skills.

• Verbal and written communication skills.

• Analytical skills required.

• Problem-solving skills required.

• Ability to work independently and as part of a team required.

• Knowledge of Microsoft Office required. 

• Ability to offer leadership and management of frontline research staff.

Working Conditions

• Office work setting and outpatient clinic/clinic setting.

 

Application Documents

• Resume (required)

• Cover Letter (preferred)

• References (3) (preferred)

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.

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