Clinical Research Coordinator 2, Surgery

University of Chicago

University of Chicago

Chicago, IL, USA
Posted on Friday, September 22, 2023

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 2 (CRC2) is a specialized researcher working with the Principal Investigator (PI), Co-Investigator(s) and other study personnel, and under the direction of departmental, clinical research manager. With limited supervision and/or guidance, the CRC2 works with the PI, Co-Investigator(s), department, and sponsoring agencies to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.

Responsibilities

Research Conduct/Study Management:

  • Manages multiple concurrent moderately complex clinical trials that may include national level and multi-institutional pharmaceutical.

  • 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.

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

  • Identifies adverse events and protocol deviations or violations, reports findings to PI, sponsor and IRB under general direction of clinical research manager.

  • Organizes and actively participates in site visits from sponsors and other relevant study meetings.

  • Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.

Data Management:

  • 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.

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

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

Regulatory Compliance:

  • Works closely with Regulatory Manager to maintain accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, and study related communication.

  • Ensures compliance with federal regulations and institutional policies.

  • May mentor CRC1 or other CRC2 staff on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study.

Other:

  • Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.

  • Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

  • 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 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

  • Bachelor’s degree.

  • Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials Management & Regulatory Compliance certification.

Experience:

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

Preferred Competencies

  • Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.

  • Demonstrated ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

  • Strong organizational skills.

  • Strong communication skills (verbal and written).

  • Strong data management skills and attention to detail.

  • Ability to participate in protocol review and clinical trials evaluations.

  • Knowledge of medical terminology/environment.

  • Ability to handle competing demands with diplomacy and enthusiasm.

  • Excellent time management and ability to prioritize work assignments.

  • Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.

  • Familiarity with Good Clinical Practices (GCP).

  • Ability to read and understand clinical trials protocols.

  • Understanding of the IRB submission and review process and when and how to apply for IRB review.

  • Understanding of the federal research regulations and the ability to identify the federal research organizations’ role in regulating human research participation.

  • Ability to absorb large amounts of information quickly.

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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