Department
BSD NEU - Clinical Research Staff
About the Department
Job Summary
This position 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.
The job independently manages the collection, documentation, analysis of complex clinical studies, and reporting of clinical research data. Provides input into the strategic, administrative, and operational decisions that impact clinical research conducted across the University.
Responsibilities
Assists with or plans and implements the clinical study goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data; processes blood and urine specimens.
Acts as a liaison with medical staff, University departments, ancillary departments and/or network facilities.
Acts as a leader within the department/unit through improving clinical research practice; serves as a resource person or acts as a consultant within area of clinical expertise.
Maintains working knowledge of current protocols, and internal SOPs.
Accountable for high standards of clinical research practice and assists in the development of accountability in others.
Develops and implements procedures, maintains records, tracks progress, and conduct quality assurance on data collected.
Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations. Prepares, submits, and assists Investigators with multiple levels of research documentation, i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms.
Provides investigators with guidance regarding protocol requirements. Maintains regulatory documentation.
Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
Prepares for and assists with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
Attends continuing education and training opportunities relevant to job duties.
Accountable for all tasks in complex clinical studies.
Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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Preferred Qualifications
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 sensitive matters with tact and discretion.
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
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
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
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity 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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