Clinical Research Nurse
3 days ago
Thank you for your interest in joining our team Please review the job information below.
General Purpose of Job
The Clinical Research Associate is a research professional with education and training in the conduct of clinical trials. In this role you will work closely with the team and facilitate communication between other members of the healthcare team and patients/families. You will support clinical research studies through COG at Driscoll Children's Hospital under the direct supervision of the Principal Investigator.
The CRA has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. The CRA makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with Good Clinical Practice (GCP), and with applicable sponsor and regulatory requirements.
Essential Duties and Responsibilities
- Maintains utmost level of confidentiality at all times
- Adheres to hospital policies and procedures
- Demonstrates business practices and personal actions that are ethical and adhere to corporate compliance and integrity guidelines
- Serves as a liaison for clinical staff for issues related to clinical trial management
- Serves as a point of contact for the sponsor and other entities involved in clinical research studies
- Assists with processing contracts, agreements, and work orders for approval in accordance with DCH contract management guidelines and facilitates grant management with the accounting department, under the direction of the Clinical Research Nurse or Program manager.
- Assists with collecting internal quality data, generates reports, and presents performance data reports and discusses findings at appropriate forum.
- Develops goals annually to address the specific departmental needs
- Attends and participates in meetings that may require travel
- Attends and participates in department and hospital meetings as required
- Assists with distribution of study information to appropriate parties
- Receives training and maintains competency with sponsor's electronic data capture systems as needed
- Verifies study eligibility and study enrollment requirements with source documents
- Obtains consent/assent for research participation in accordance with applicable federal, state, and local regulations and institutional policies/procedures
- Ascertains that data collected by staff are complete and verifiable from source documents
- Assists with preparation of source document templates in accordance with the protocol, case report forms, and electronic data capture systems.
- Collaborates with pharmacists, re: drug inventory, storage and monitoring requirements, subject visits and dispensing
- Collaborates with clinical staff and ancillary departments for protocol training and scheduling and care for enrolled subjects
- Collects and submits study data within sponsor-required timelines
- Coordinates with laboratory personnel to collect and ship specimens to study central laboratories in accordance with protocol requirements
- Participates in site selection visits, study initiation visits, and monitoring or inspection visits, including facility tours, source document compilation and verification.
- Maintains research charts for study participants in accordance with DCH guidelines.
- Ensures compliance with protocol related treatments and evaluations by maintaining a quality assurance process and assisting the PI and Program Manager with designing and implementing process improvement as needed
- When needed, assists in the preparation of documents for Institutional Review Board submission including informed consent, protocol amendments and safety reports.
- Assists with development of department SOPs; provides suggestions for improvement
- Practices and promotes cost-effective use of resources and makes recommendations for improvement
- Promotes exceptional customer service and support of the plan of care per protocol
- Self-directed in developing their own performance in relation to professional standards and relevant statues and regulations.
- Performs other duties as necessary
- Degree in a science discipline from a college or university with a 4-year bachelor's preferred; OR one to two years related experience and/or training; or equivalent combination of education and experience in conducting clinical trials
- Research experience with knowledge of the conduct of clinical trials preferred but not required
- Hematology/Oncology experience is preferred but not required
- Certificates, Licenses, Registrations
- Society for Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification required following 2 years of employment
- Current professional nurse licensure in the state of Texas if applying with a nursing background
- Basic Life Support (BLS) through the AHA is required upon hire and maintained as required.
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