Clinical Research Coordinator 2
Hyde Park Campus
About the Unit
In the Department of Pediatrics at the University of Chicago, we strive to provide the highest level of complex care for children from diagnosis and treatment to conducting research to find promising new therapies with a focus on teaching. We are committed to advancing the frontiers of knowledge, and the education and training of future clinical pediatricians, subspecialists, educators, clinical investigators and physician-scientists. The Department of Pediatrics is a dynamic, stimulating place to work, and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles. The Pediatric Clinical Trials Office (Peds CTO) is an existing centralized support office that provides services and high level guidance to individuals (faculty, investigators, research staff, and clinic coordinators from the University and Hospital) involved in human subjects research. The Peds CTO is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research. The Clinical Research Coordinator 2 will provide support to the faculty in the section of Neonatology within the Department of Pediatrics. Preterm infants are at risk for poor neurodevelopmental outcome due to their degree of prematurity, hospital course, and home environment. We are studying the changes in the bacterial colonization patterns of these infants in the context of their home environment and to identify a potentially modifiable factor that may influence brain development and thus ensure school readiness for these vulnerable infants. This position is wholly funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.
- 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 limited direction of departmental, clinical research manager and/or the Office of Clinical Research (OCR).
- With limited supervision and/or guidance, the CRC2 works with the PI, Co-Investigator(s), department, sponsoring agencies, and/or the OCR to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.
- The CRC2 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.
- The CRC2 plays an instrumental role in ensuring compliance with the study protocol, Federal guidelines, Local guidelines, and in accordance with Good Clinical Practice (GCP).
- The CRC2 may assist with the training and/or mentoring of 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.
- Depending on workload, some evening and weekend hours may be required.
- Research Conduct/Study management:
- 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 multi-centered cooperative group 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.
- Responsible for the oversight/monitoring of all clinical trial expenses; reviews the protocol plan to differentiate standard of care versus research to ensure that clinical care expenses, personnel effort, site initiation costs, IRB fees, pharmacy costs, equipment, and supplies are tracked and captured as direct costs to the clinical trial.
- Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques
- Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, noting severity and causality and attribution of the adverse events; reports findings to PI, sponsor and IRB under general direction of department, clinical research manager and/or the Office Clinical Research.
- 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:
- 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.
- 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.
- Ensures compliance with federal regulations and institutional policies.
- May assist with preparation of protocols, amendments and other necessary documents for review by the IRB and sponsor.
- Other Duties:
- May train and/or 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 duties as assigned.
- Demonstrated ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others required.
- Ability to communicate with tact and diplomacy required
- Strong organizational skills required
- Strong communication skills (verbal and written) required
- Ability to handle sensitive matters with tact and discretion required
- Excellent interpersonal skills required
- Strong data management skills and attention to detail required
- Ability to participate in protocol review and clinical trials evaluations required
- Ability to handle competing demands with diplomacy and enthusiasm required
- Excellent time management and ability to prioritize work assignments required
- Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat required
- Ability to read and understand clinical trials protocols required
- Ability to absorb large amounts of information quickly required
- Adaptability to changing working situations and work assignments required
ADDITIONAL JOB DESCRIPTION:
Education, Experience, and Certifications:
- Bachelor's degree required
- Minimum of 2 years of clinical research experience or relevant experience required
- Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, and multi-site trials) required
Licenses and Certifications:
- Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials Management & Regulatory Compliance certification preferred
Technical Knowledge or Skills:
- Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines required.
- Knowledge of medical terminology / environment required
- Familiarity with Good Clinical Practices (GCP) required
- Understanding of the IRB submission and review process and when and how to apply for IRB review required
- Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation required
Working Conditions and Physical Requirements (if applicable):
- Exposure to human tissue or other biological agents.
The following documents are required to be considered for this position:
- Resume / CV
- Cover Letter
- Reference List
(NOTE: When applying, all required documents, including cover letters, MUST be uploaded under the Resume/CV section of the application.)
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
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