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Senior Clinical Research Coordinator
Job Description
Department
About the Department
Job Summary
Responsibilities
The Sr. CRC acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others.
By performing these duties, the Sr. CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies. other related aspects of the clinical study.
Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.
Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
Serve as a resource person or act as a consultant within area of clinical expertise.
Act as a leader within the department/unit through improving clinical research practice and serving as a resource.
Maintain working knowledge of current protocols, and internal SOPs.
Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
Provide Investigators with guidance regarding protocol requirements.
Maintain regulatory documentation.
Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
Provide direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
Attend continuing education and training opportunities relevant to job duties.
Implements Good Clinical Practices (GCP) and all relevant current local, state, and federal laws, regulations, policies and procedures. Develops and implements consistent standards and protocols.
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.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.---
Work Experience:
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Certifications:
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Preferred Qualifications
Education:
Bachelor's degree.
Experience:
Clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).
Preferred Competencies
Aware of safety hazards and take appropriate precautions.
Communicate in writing.
Communicate orally.
Comprehend technical documents.
Condense complicated issues to simple summaries that can be understood by a variety of constituents.
Create and deliver presentations.
Develop and manage interpersonal relationships.
Exercise absolute discretion regarding confidential matters.
Follow written and/or verbal instructions.
Give directions.
Handle stressful situations.
Learn and develop skills.
Maintain a high level of alertness.
Pay attention to detail.
Perform multiple tasks simultaneously.
Prioritize work and meet deadlines.
React effectively, quickly, calmly, and rationally during conflicts and emergencies.
Train or teach others.
Work effectively and collegially with little supervision or as member of a team.
Work independently.
Application Documents
Resume (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
Role Impact
FLSA Status
Pay Frequency
Scheduled Weekly Hours
Benefits Eligible
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Posting Statement
Employees must comply with the University’s COVID-19 vaccination requirements. More information about the requirements can be found on the University of Chicago Vaccination GoForward .
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 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.
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