Children's Hospital Colorado · 12 hours ago
Clinical Research Coordinator Associate Infectious Disease
Aurora, CO
Part-time
Onsite
Entry Level
$21.35/hr - $32.03/hr
4+ years expChildren's Hospital Colorado is seeking a Clinical Research Coordinator Associate to support the Infectious Disease Research team. The role involves coordinating clinical research programs, assisting with data collection and regulatory submissions, and maintaining ethical conduct in research to improve child health outcomes.
BiotechnologyChildrenHealth CareHospital
Responsibilities
Documentation/Data Collection - Prepares and takes part in site initiation, monitoring, closeout visits, document storage activities, and related training. May assemble the necessary parties to ensure that all required agreements are in place. Utilizes and assists senior team members on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations. Scores tests, enters data, and completes required forms accurately and according to protocol. Assists with the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies identifies issues recommends solutions
Regulatory - Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission
Study Participation - Screens, schedules, consents participants in assigned clinical research programs and/or studies. With guidance, explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Engages with senior study team to maintain participant recruitment and retention rates and assists with participants with individual needs, collects information to determine feasibility. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens
Protocol - Trains in developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing/interviews according to all assigned regulatory and organizational protocols. Trains in completing and submitting AE reports, according to institution and sponsor-specific reporting requirements. Assists with the development of proposals or protocols as directed. Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level
Human Subject Research Protection - Maintains compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. Trains in the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Trains on professional guidelines and code of ethics
Team Coordination - Proactively includes others in decision making and escalates issues to leadership as necessary. Learns various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims
Quality Assurance - Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Recognizes and reports vulnerabilities related to security of physical and electronic data. Assists with recognizing trends related to data quality and escalates as appropriate. Adheres to and participates in the development and assessment of quality assurance. Assists with identifying issues related to operational efficiency and shares results with team members
Budgets/Financials - Participates in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing
Qualification
Required
Bachelor in a related field
High School diploma or GED + four (4) years clinical, clinical support, or clinical research related experience may be considered in lieu of minimum education requirement
Benefits
Paid time off
Medical/dental/vision insurance
Company provided life and disability insurance
Paid parental leave
403b employer match (retirement savings)
A robust wellness program
Access to professional development tools, including an education benefit to help you advance your career
Annual employee bonus program that rewards eligible team members based on organizational performance
Annual base pay increases to eligible team members based on their performance over the previous year
Company
Children's Hospital Colorado
At Children’s Hospital Colorado, we know that kids aren’t just mini adults.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$0.65MKey Investors
Hyundai Hope On WheelsCOPIC Medical FoundationCOPIC Companies
2024-08-28Grant· $0.35M
2022-09-27Grant· $0.3M
2022-03-11Grant
Leadership Team
Adam Hill
Section Head of Pediatric Palliative Medicine
Recent News
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