The Global Institute for Hispanic Health is expanding research at Driscoll Children's Hospital into new specialty areas, through sponsored clinical trials and investigator initiated research. We are seeking an experienced Clinical Research Coordinator to join our team and support this growing clinical research department. The successful applicant will have experience conducting industry sponsored clinical trials in accordance with Good Clinical Practice, International Conference on Harmonization and regulations for protecting human research participants. Certification through a research organization preferred, and required within 2 years of hire. This fast-paced environment requires critical thinking skills, excellent written and verbal communication, and meticulous organization/attention to detail. Your initiative and commitment will help us continue to build an excellent foundation for high quality ethical research.
General Purpose of Job:
The Clinical Research Coordinator (CRC) is a research professional with education or training in the conduct of clinical trials. They coordinate the screening, enrollment, and data reporting for patients enrolled in clinical research studies, serve as a protocol resources for clinical staff caring for patients on-study, and serve as a back-up for other research staff.
The CRC 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 CRC 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, 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 templatesin 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 ammendments 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
Education and/or Experience
Bachelor of Science degree in a science discipline from a four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience
Research experience with knowledge of the conduct of clinical trials preferred but not required.
Professional nurse licensure in the state of Texas if applying with a nursing background
Certificates, Licenses, Registrations
Society for Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification following 2 years of employment
Basic Life Support (BLS) through the AHA is required upon hire and maintained ongoing.
About Driscoll Children's Hospital
Driscoll Children's Hospital distinguishes itself as the preferred hospital to work for in Texas and the South Central United States. Located on the Texas Gulf Coast just two blocks from Corpus Christi Bay, Driscoll Children's Hospital truly is an oasis in today's healthcare environment.