Clinical Research Coordinator 2, Transplant Surgery

Department
 

BSD SUR - Transplant Surgery: Research

About the Department
 

Since the founding of the Department in 1927, many scientists, including our very own Nobel Prize-winning Charles B. Huggins, MD, have made important discoveries about various diseases and treatment protocols that still serve as a basis for standard clinical practice today.
Today, our scientists continue to embody the ethos of the University of Chicago's commitment to open, rigorous, and intense inquiry. Our laboratories tackle some of today's most complex biomedical challenges, including research into immunotolerance, vaccine stabilization and bioengineering.
This ongoing work and achievement would not be possible without the cohesive effort of the faculty and staff. We are always looking for individuals who are willing to work in our dynamic and collaborative environment.

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.
• Working closely with the Transplant Institute to identify potential patients in all clinics.
• Conduct all sponsor-related visits and facilitate as an liaison between sponsor and PI.
• Review and meet regularly with PI to review study portfolio.
• Facilitate in the planning and identifying the workflow pathway of new clinical trials.
• Participate in study start-up activities.
• Work closely with Transplant pharmacy to ensure effective workflow and success of trials.
• Work with the lab team to process and collect samples for internal processing.
• 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:

• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
• Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.
• 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.
• 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

Education:

• Bachelor’s degree.

• Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials.

Experience:

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

Licenses and Certifications:

• Management & Regulatory Compliance certification.

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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