Clinical Research Coordinator 2

University of Chicago

University of Chicago

Chicago, IL, USA
Posted on Thursday, October 19, 2023

Department

BSD MED - Hematology and Oncology - Clinical Research Staff - Cluster 2


About the Department

The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.


Job Summary

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRC2 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 study.

Responsibilities

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

  • Recruits and interviews potential study patients with guidance from PI and other clinical research staff.

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

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

  • Coordinates 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.

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

  • 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.

  • Performs assessments at visits and monitors for adverse events.

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

  • Protects patients' and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.

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

  • 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.

  • Understands 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.

  • Ensures compliance with federal regulations and institutional policies.

  • May prepare and maintain protocol submissions and revisions.

  • May assist in the training of new or backup coordinators.

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

  • Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

  • 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:

  • Bachelors degree.

Experience:

  • Clinical research experience or relevant experience.

  • Experience coordinating multiple studies such as investigator initiated, industry sponsored, and 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/CV (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

37.5


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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