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University of Chicago Clinical Research Coordinator 2 in Chicago, Illinois

Please make sure to read the job posting in its entirety as it reflects both the University roles and responsibilities, followed by the specific description.
Department

2012213 Medicine-Dermatology

About the Unit

Dermatology has a proud heritage at The University of Chicago, dating back to the 1930s, making it one of the oldest sections in the Department of Medicine. Among its distinguished chiefs are Samuel Becker, who was one of the pioneers of American dermatology, Stephen Rothman, MD, who wrote the first modern textbook on the basic science of the skin and Allan Lorincz, MD, who has over 50 years of service in the Chicago Dermatological Society.

Job Family

Research

Responsible for all aspects of research projects and research facilities. Plans and conducts clinical and non-clinical research; facilitates and monitors daily activities of clinical trials or research projects. Directs engineering and technical support activities to develop and maintain tools and computational methods needed to gather and analyze data.

Career Track and Job Level

Clinical Research

Manages, facilitates, and monitors the daily activities of clinical research and clinical trials. Performs a variety of duties involved in the collection, documentation, analysis and reporting of clinical research and clinical trial data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research and clinical trials conducted across the University.

P1: Performs routine assignments in the entry level to a professional job progression. Typically requires a college or university degree or the equivalent work experience that provides knowledge and exposure to fundamental theories, principles and concepts. Develops competence by performing structured work assignments. Uses existing procedures to solve routine or standard problems. Receives instruction, guidance and direction from others.

Role Impact

Individual Contributor

Responsibilities

The job performs routine assignments related to the documentation, analysis, and reporting of research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

1) Performs various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to the case report., 2) Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics., 3) Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups., 4) Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports., 5) Performs other related work as needed.

Unit-specific Responsibilities

1)Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.

2) Recruit and interview potential study patients with guidance from PI and other clinical research staff.

3) Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.

4) Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.

5) Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.

6) Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.

7) Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.

8) Performs assessments at visits and monitors for adverse events.

9) Organizes and attends site visits from sponsors and other relevant study meetings.

10) Partner with PI(s) to coordinate administrative aspects research grant proposals.

11) Ensure laboratory day-to-day operations are running efficiently.

12) Assist with coordination of research related conferences and events.

13) Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.

14) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.

15) Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.

16) Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.

17) Ensures compliance with federal regulations and institutional policies.

18) May prepare and maintain protocol submissions and revisions.

19) May assist in the training of new or backup coordinators

Unit-preferred Competencies

1) Ability to communicate with tact and diplomacy.

2) Strong organizational skills.

3) Strong communication skills (verbal and written).

4) Ability to communicate with tact and diplomacy.

5) Ability to handle sensitive matters with tact and discretion.

6) Excellent interpersonal skills.

7) Strong data management skills and attention to detail.

8) Ability to participate in protocol review and clinical trials evaluations.

9) Knowledge of medical terminology / environment.

10) Ability to handle competing demands with diplomacy and enthusiasm.

11) Excellent time management and ability to prioritize work assignments.

12) Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.

13) Familiarity with Good Clinical Practices (GCP).

14) Ability to read and understand clinical trials protocols.

Education, Experience, and Certifications

Minimum requirements include a college or university degree in related field.

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

Preferred Qualifications

Education

1)**Bachelor's degree

Experience

1)2 years of clinical research experience or relevant experience

2)Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials)

Required Documents

1) Resume

2) Cover letter

Note:When applying, all required documents MUSTbe uploaded under the Resume/CV section of the application.

FLSA Status

Exempt

Pay Frequency

Monthly

Pay Grade

Depends on Qualifications

Scheduled Weekly Hours

40

Benefits Eligible

Yes

Drug Test Required

Yes

Health Screen Required

Yes

Motor Vehicle Record Inquiry Required

No

Posting Date

2019-08-01-07:00

Remove from Posting On or Before

2020-02-01-08:00

Posting Statement

The University of Chicago is an Affirmative Action/EqualOpportunity/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.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

  • Posted 30+ Days Ago
  • Full time
  • JR05992
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