Clinical Research Coordinator 2
Hyde Park Campus
About the Unit
The Comprehensive Care Physician (CCP) Program is seeking a motivated Advanced Practice Nurse (APN) interested in providing home based primary care. The practitioner will be a part of a multidisciplinary team dedicated to providing care to chronically ill patients. We are looking for an innovator to develop patient care plans and to serve as an adjunct to the primary care physician.
The Clinical Research Coordinator 2 (CRC2) is a specialized researcher working with the Principal Investigator (PI) Dr. David Meltzer, 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 protocols and performs a variety of duties involved in the collection, compilation, documentation and reporting of data. The CRC2 plays an instrumental role in ensuring compliance with the study protocol, Federal guidelines, Local guidelines in accordance with Good Clinical Practices (GCP). The CRC2 will work with regulatory agents, the Institutional Review Board, study participants, 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.
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.
Research Conduct/Study Management:
- Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
- Recruit and interview potential study patients with guidance from PI and other clinical research staff.
- Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
- Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
- Coordinate 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.
- Protect 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.
- 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.
- Understand the federal research regulations and identify the federal research organizations' role in regulating human research participation.
- May prepare and maintain protocol submissions and revisions.
- 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.
- Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat 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.
Education and Experience:
- 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, multi-site trials) required.
- Cover Letter
NOTE: When applying, all required documents 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?
Remove from Posting On or Before
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