| Location: Hyde Park Campus Job Description: 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.Â
- 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.Â
- 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.Â
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.
- 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.
- 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: - Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
- Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
- Performs other related work as needed.
Preferred Qualifications Education: - Bachelorâ™s degree.
- Continuing education such as ACRP, SoCRA or the Graham School Clinical Trials Management & Regulatory Compliance certification.
Experience: - Minimum of 2 years of clinical research experience or relevant experience.
- Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, and multi-site trials).
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.
- Ability to communicate with tact and diplomacy.
- Strong organizational skills.
- Strong communication skills (verbal and written).
- Ability to handle sensitive matters with tact and discretion.
- Excellent interpersonal skills.
- 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 organizationsâ™ role in regulating human research participation.
- Ability to absorb large amounts of information quickly.
- Adaptability to changing working situations and work assignments.
Application Documents - Resume (required)
- Cover Letter (required)
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected 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 the Applicant Inquiry Form. The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637. |
