Clinical Research Coordinator 2, Trauma Surgery jobs in United States
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University of Chicago · 5 months ago

Clinical Research Coordinator 2, Trauma Surgery

The University of Chicago is a prestigious institution known for its commitment to rigorous inquiry and significant scientific contributions. They are seeking a Clinical Research Coordinator 2 to manage complex clinical trials, ensuring compliance, data integrity, and participant safety throughout the research process.

Higher Education
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H1B Sponsor Likelynote

Responsibilities

Manages multiple 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
Conducts all sponsor-related visits and acts as a liaison between sponsor and PI
Reviews and meets regularly with PI to review study portfolio
Participates in study start-up activities
Works 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
Collects, processes, ships, and stores 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
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
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
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
Assists with various professional, organizational, and operational tasks under moderate supervision
Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks
Performs other related work as needed

Qualification

Clinical trial coordinationData managementRegulatory complianceClinical Practices (GCP)Medical terminologyPatient evaluationMicrosoft Office proficiencyAttention to detailCommunication skillsProblem solvingTeam collaboration

Required

Minimum requirements include a college or university degree in related field
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline
Resume (required)
Cover Letter (required)

Preferred

Bachelor's degree
Continuing education such as ACRP, SoCRA, or the Graham School Clinical Trials
Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, and multi-site trials)
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 data management skills and attention to detail
Ability to participate in protocol review and clinical trials evaluations
Knowledge of medical terminology
Ability to handle competing demands with diplomacy and enthusiasm
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

Benefits

Health, retirement, and paid time off

Company

University of Chicago

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One of the world’s great intellectual destinations, the University of Chicago empowers scholars and students to ask tough questions, cross disciplinary boundaries, and challenge conventional thinking to enrich human life around the globe.

H1B Sponsorship

University of Chicago has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (341)
2024 (318)
2023 (285)
2022 (233)
2021 (179)
2020 (172)

Funding

Current Stage
Late Stage

Leadership Team

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Benedicte Nolens
Distinguished Executive in Residence
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