Clinical Research Coordinator 2 (GI)
Hyde Park Campus
About the Unit
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 subject's 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. Research in pediatric inflammatory bowel disease (IBD) at the University of Chicago is focused on identifying the causes, natural history, complications and role of therapeutic interventions in children and adolescents with IBD. Through this knowledge, it will be possible to improve the outcomes as well as develop more effective treatments for patients with pediatric IBD. The Pediatric IBD research program is supported by funding from private philanthropic sources and extramural contracts received from the National Institutes of Health, Crohn's and Colitis Foundation of America, and pharmaceutical companies in the form of clinical drug trials.
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 director/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 Inflammatory Bowel Disease clinical research studies 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 will work with regulatory agents, the Institutional Review Board personnel, study subjects, Department staff, and hospital staff. This position entails all aspects of conducting clinical research: recruiting/interviewing, screening, consenting, enrollment, subject follow-up, completion of case report forms and adverse event reporting. The CRC2 will educate subjects and parents/guardians about study procedures to be performed. He/she will schedule visits and describe what information needs to be reported between and during visits including potential side effects of study-related agents or procedures. The CRC2 will record data in databases, as required, and will perform medical chart reviews. He/she will maintain accurate and complete documentation of signed informed consent form, relevant Institutional Review Board approvals, source documentation, Case Report Forms, drug dispensing logs, and study-related communication. May obtain, process, and transport or ship specimens to appropriate laboratory according to established aseptic technique. Monitors billing and payment for research studies ensuring bills are processed and payments are collected.
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, 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; monitors data 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 director 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.
- 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, 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.
- Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, 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 assist with preparation of protocols, amendments and other necessary documents for review by the IRB and sponsor.
- Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines required.
- 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.
- Knowledge of medical terminology / environment required.
- Ability to handle competing demands with diplomacy and enthusiasm required.
- Excellent time management and ability to prioritize work assignments required.
- Familiarity with Good Clinical Practices (GCP) required.
- Ability to read and understand clinical trials protocols 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.
- Ability to absorb large amounts of information quickly required.
- Adaptability to changing working situations and work assignments required.
- Ability to communicate orally
- Ability to communicate in writing
- Ability to comprehend technical documents
- Ability to condense complicated issues to simple summaries that can be understood by a variety of constituents
- Ability to develop and manage interpersonal relationships
- Ability to exercise absolute discretion regarding confidential matters
- Ability to follow written and/or verbal instructions
- Ability to read
- Ability to give directions
- Ability to prioritize work and meet deadlines
- Ability to handle sensitive matters with tact and discretion
- Ability to handle stressful situations
- Ability to pay attention to detail
- Ability to learn and develop skills
- Ability to perform multiple tasks spontaneously
- Ability to react effectively, quickly, calmly and rationally during conflicts and emergencies
- Ability to work effectively and collegially with little supervision or as a member of a team
- Ability to work independently
- Ability to work with frequent interruptions
- Ability to work with people from diverse cultures and backgrounds
- Active listening skills
- Editing and proofreading skills
- Critical thinking skills
- Decision making skills
- Time management skills
- Problem solving skills
- Interpersonal skills
- Organizational skills
- Planning skills
- Reasoning skills
- Quantitative and analytical skills
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
- Ability to participate in protocol review and clinical trials evaluations required
- Familiarity of Good Clinical Practices (GCP) 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:
- Experience submitting protocols to the IRB preferred
- Experience with REDCap database management preferred
- Familiarity with electronic medical record system (Epic) and terminology preferred
- Experience working on gastroenterology or IBD-based clinical trials preferred
- Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat required.
Working Conditions and Physical Requirements (if applicable):
- Ability to bend, crouch or stoop
- Ability to carry or lift loads up to 25lbs
- Exposure to human blood, human blood components and/or products made from human blood
- Exposure to laboratory chemicals
- Ability to stand for 2 hours to 4 hours
- Ability to sit for 4 hours or more
- Ability to travel to various off-campus locations
- Ability to travel to various on-campus locations
- Ability to use computers extensively for 4 hours or more
- Ability to use Standard Office Equipment
- Cover Letter
- Curriculum Vitae
- Reference Contact Info
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?
Background Check Required?
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