UTMB Faculty Group Practice · 1 month ago
Coordinator Clinical Research Senior, Center for OCR - Galveston
Galveston, Texas, United States
Full-time
Onsite
Senior Level
5+ years expUTMB Health is a healthcare organization seeking a Senior Clinical Research Coordinator to manage clinical research projects. The role involves gathering patient data, ensuring compliance with regulations, and supervising the preparation of regulatory documents.
Hospital & Health Care
Responsibilities
Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities
Under the direction of the PI, supervises and assists with the preparation and submission of all IRB and Regulatory Documents to obtain final approval and may draft various communications with Sponsor
Attends and participates in the Investigator meeting
Reviews goals and requirements of any new protocols and coordinates study initiation
Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals
Assesses staffing needs based upon current research activity and implements changes in staffing as needed
Participates in protocol initiation visits
Plans and designs source documentation for protocol
Develops assessment tool per protocol to use in clinical research and teaches research team and hospital personnel how to use the assessment tool as allowed per medical practice
Develops procedures for laboratory collection and storage
Assists in processing and shipping lab specimens; retrieves and/or sends identified research specimens certified if indicated as per regulations
Maintains accurate source documentation and appropriate forms as per protocol including participant records, drug documentation, reconciling study drug accountability; monitors documentation for quality and accuracy
Conducts reviews of on-going studies and oversees quality assurance on ongoing protocols; productive working relationship with the study monitor
Precepts new clinical research staff and educates research staff regarding scientific aspects of studies
Provides performance management for staff under direction of PI
Assesses communication process within Department and/or services required by the protocol
Elicits relevant data from sources outside of the hospital
Assists PI in budget development; may monitor ledgers
Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; ensures return of test article /clinical supplies; maintains regulatory standards
Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary; mentors all clinical research personnel regarding enrollment/recruitment
Monitors participants labs and notifies the PI of laboratory findings
Serves as a role model and resource for the clinical research staff
May assist PI in obtaining Informed Consent from study participant and documents appropriately. Adheres to internal controls established for department
Qualification
Required
Bachelor's degree and five years experience as clinical research coordinator or equivalent experience
Preferred
Previous clinical research experience
Company
UTMB Faculty Group Practice
The University of Texas Medical Branch (UTMB) Faculty Group Practice (FGP) is comprised of over 950 faculty physicians and advanced practice providers who drive UTMB’s mission of improving health by delivering innovative education and training, pursuing cutting-edge research, and providing the highest quality patient care.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase