Clinical Research Coordinator 3

Department
 

BSD SUR – Research Services: Clinical Research

About the Department
 

Operating since 1927 on a strong foundation of multidisciplinary clinical and academic excellence, the University of Chicago Department of Surgery’s mission is to meet the most challenging and complex health problems on both a local and global scale.
Many of our faculty members are known for their contributions to the advancement of groundbreaking surgical procedures and techniques, including minimally invasive surgery. In addition to our department’s clinical work, our scientists pursue a diverse range of basic, translational, and clinical research projects, including studies on the gut microbiome, tissue bioengineering, stem cell research, cancer, and immunotolerance.
This ongoing work and achievement would not be possible without the cohesive effort and commitment of the faculty and staff. We are looking for high energy, collaborative individuals who share our commitment to improving the health of patients in the community and beyond.

Job Summary
 

The Clinical Research Coordinator 3 is a specialized researcher working with the Principal Investigator (PI), Co-Investigator(s) and other study personnel, and under limited direction of the Associate Director of Clinical Research. The Clinical Research Coordinator 3 independently manages, facilitates and monitors the daily activities of multiple moderately complex clinical trials and performs a variety of duties involved in the collection, compilation, documentation and reporting of clinical research data.

Responsibilities

• Independently trains clinical research coordinators on the day to day tasks required to conduct and execute a research study and the Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study.

• Serves as lead coverage when a clinical research coordinator is unavailable.

• Responsible for the oversite and execution of moderately complex clinical trials.

• Assists the Associate Director of Clinical Research on the following: site feasibility, completion of new study questionnaires, coordination of communications across facilities and departments, and scheduling of feasibility and site initiation visits, which include research staff and outside offices.

• Assists with completing study start-up for new research protocols such as the completion of the schedule of events (schema) and schema review memo.

• Oversees the research study close out visits and works with the sponsor, regulatory staff and coordinators.

• Ensures all training and protocol specific documents are available to staff via Box or shared drive.   

• Assists the Associate Director of Clinical Research with the growth of Vascular Surgery research portfolio.

• Responsible for tracking study subjects adverse events (AE) and serious adverse events (SAE) and reporting them to the sponsor and IRB in a timely fashion.

• Assists the Associate Director of Clinical Research with internal clinical trials management system.

• Manages all aspects of conducting clinical trials from startup to closeout for multiple concurrent moderately complex clinical trials that may include national level, multi-institutional pharmaceutical trials and intergroup studies.

• Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.

• Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.

• Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.

• Participates in site visits from sponsors and other relevant study meetings. 

• Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.

• Protects patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.

• 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.

• 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.

• Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.

• Performs other related work as needed.

Minimum Qualifications
 

Education:

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

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Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Experience:

• Prior clinical research experience in an academic medical center.

Preferred Competencies

• Excellent oral and written communication skills.

• Strong project management skills, strategic problem solving and attention to detail.

• Ability to understand complex protocols to assist with billing and budget discussions.

• Motivated and detail-oriented.

• Strong interpersonal skills.

• Commitment to providing a high level of service.

• Ability to work independently and as part of a team.

• Ability to handle sensitive and confidential situations and information with absolute discretion.

• Ability to work well under pressure.

• Knowledge of Microsoft Office.

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
 

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. 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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