Temporary Clinical Research Coordinator II
University of Chicago
Department
BSD OBG - Uro
About the Department
Job Information
Job Summary:
The Temporary Clinical Research Coordinator supports the execution of moderately complex clinical research studies from initiation through close out. This role assists with coordinating study activities, maintaining regulatory compliance, managing study documentation, and facilitating communication across investigators, sponsors, and research teams.
The coordinator helps conduct clinical and non clinical research activities, supports participant recruitment and study visits, collects and manages research data, and contributes to study reporting and dissemination efforts. The role operates under the guidance of the study team and adheres to institutional, state, and federal regulations to ensure studies are conducted efficiently, ethically, and in alignment with sponsor requirements.
Responsibilities:
Develop study protocols, CRFs, and other study documents.
Develop instructional regulatory body (IRB) protocols, amendments and other documents as well as respond to IRB stipulations and requirements.
Collect, archive subjects’ data. Assist in scientific data dissemination. Develop, write, edit, submit and publish scientific manuscripts and present scientific abstract at national and international conferences.
Participate in local and national meetings related to multi center trials and participate in regular phone/skype meetings related to clinical research.
Assist in developing and submitting regular progress reports to NIH and other sponsors of clinical research studies.
This job provides technical and administrative support in a laboratory environment performing basic laboratory techniques, research and analysis under direction.
Provides routine or standardized laboratory duties by collecting data in support of research projects under direct supervision.
Collects and enters data. Assists in analysis of data and with preparation of reports, manuscripts and other documents.
Complies with institution, state and federal regulatory policies, procedures, directives, and mandates.
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, subject consenting, subject recruitment, perform and supervise various study visit procedures, 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.
Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
Performs other related work as needed.
Competencies:
Ability to independently coordinate and manage moderately complex clinical research studies from start up through close out.
Knowledge of IRB processes, regulatory requirements, and institutional, state, and federal research policies.
Strong data management and analytical skills, including experience with REDCap, Excel, and other research data systems.
Understanding of research methodologies and basic laboratory techniques applicable to clinical and non clinical studies.
Sound problem solving skills with the ability to exercise professional judgment in resolving study related operational, compliance, and financial issues.
Effective collaboration and communication skills when working with investigators, sponsors, multidisciplinary teams, and external partners.
Strong organizational skills and attention to detail with the ability to manage multiple studies and competing priorities.
Additional Responsibilities
Education, Experience, or Certifications:
Education:
High School Diploma required.
Bachelor’s degree in research or a related field preferred.
Experience:
At least two years of related work experience preferred.
Previous clinical trials experience preferred.
Previous IRB protocol experience preferred.
Working Conditions:
Outpatient clinical environment (primarily) and lab environment.
Ability to stand for extended periods.
Ability to use computer for extended periods.
Required Documents:
Resume
Cover Letter
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Frequency
Hourly
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
Posting Statement
The University of Chicago is an equal employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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.
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.
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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