- Leads within the department/unit through improving clinical research practice and serves as a resource to others.
- 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.
- Assists with or plans and implements the clinical study's goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data.
- Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities.
- Serves as a resource person or acts as a consultant within area of clinical expertise.
- Acts as a leader within the department/unit through improving clinical research practice and serving as a resource.
- 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 conducts 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.
- Provides direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
- Attends continuing education and training opportunities relevant to job duties.
- 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.
- Clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).
- 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.
- Resume (required)
- Cover Letter (required)
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Senior Clinical Research Coordinator - Chicago, United States - University of Chicago
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Description
DepartmentBSD MED - Gastroenterology - Clinical Research Staff
About the Department
The Section of Gastroenterology, Hepatology at The University of Chicago is consistently ranked among the best specialty nationally by U.S News and World Report.
With nearly 30 specialists on staff, our program plays a leading role in the understanding of digestive diseases and in developing innovative and successful treatments for patients.
Since forming the nation's first full-time department of gastroenterology in 1927, our physicians have continually improved treatments for digestive tract and related disorders by combining medical research, education, and patient care at the highest level.
Job SummaryThe Senior Clinical Research Coordinator (Sr.
CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Clinical Research Manager within the Section of Gastroenterology in the Department of Medicine.
While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Sr.
CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations.
ResponsibilitiesEducation:
Minimum requirements include a college or university degree in related field.
* Work
Experience:
Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.
* Certifications:* Preferred Qualifications
Experience:
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Research
Role Impact
Individual Contributor
FLSA Status
Exempt
Pay Frequency
Monthly
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
Yes
Health Screen Required
Yes
Motor Vehicle Record Inquiry Required
No
Posting Statement
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law.
Staff Job seekers in need of a reasonable accommodation to complete the application process should call 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.
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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Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.