Children's Hospital Colorado · 6 hours ago
Associate Clinical Research Coordinator - Oncology Group Center for Cancer and Blood Disorders
Aurora, CO
Full-time
Onsite
Entry Level
$21.35/hr - $32.03/hr
4+ years expChildren's Hospital Colorado is a leading institution in pediatric healthcare, focusing on innovative research and treatment for children with cancer. The Associate Clinical Research Coordinator will assist in the daily operations of clinical research studies, ensuring compliance and supporting the achievement of research objectives under supervision. This role involves data collection, regulatory submissions, participant engagement, and quality assurance within clinical research programs.
BiotechnologyFamily & CareHealthcareHospitalChildrenHealth Care
Responsibilities
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
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
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
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
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
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
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
Participates in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing
Qualification
Required
Bachelor's degree in a related field is required
High School diploma or GED, and four (4) years of clinical, clinical support, or clinical research related experience may be considered in lieu of minimum education requirement
Preferred
Ideal applicant has previous oncology experience
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
Annual base pay increases based on performance
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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