UTMB Faculty Group Practice · 6 hours ago
Coordinator, Clinical Research Obstetrics and Gynecology Research Support Unit - (Galveston/Spanish)
Galveston, Texas, United States
Full-time
Onsite
Entry Level
2+ years expUTMB Health is a prominent healthcare organization seeking a Clinical Research Coordinator for their Obstetrics and Gynecology Research Support Unit. The role involves obtaining human subject data for clinical research activities, coordinating study visits, and maintaining documentation to ensure compliance with protocols.
Hospital & Health Care
Responsibilities
Obtain human subject data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study
Schedules, coordinates, and participates in the pre-site visit and site initiation visits, coordinates study initiation
Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process
Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital
Develops and maintains productive working relationship with the study monitor; attends and participates in campus coordinator workshops
Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals
Mentors new clinical research coordinators and assistant clinical research coordinators
Assists with grant/protocol preparation and submission to IRB, OCR or OSP under direction of research coordinator under the direction of the PI and with answering IRB stipulations to obtain final approval, documents IRB approval and contract approval
Under direction of PI may draft various communications with Sponsor and/or regulatory documents to be sent to the Sponsor
May assist PI and/or research nurse coordinator in the planning and design of source documents for protocol
Assists in developing 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
Assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies
Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards
Assists with the budget development; may monitor ledgers
Adheres to internal controls established for department
May assist PI in obtaining Informed Consent from study participant and documents appropriately
Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities
Reconciles study drug accountability; maintains temperature and QC logs per protocol compliance
Adheres to internal controls and reporting structure
If appropriately trained and tested for competency, obtains Vital Signs, and performs phlebotomy: monitors participants’ labs and notifies the PI of laboratory findings
May attend and participate in the Investigator meetings
Performs related duties as required
Qualification
Required
Bachelor's degree or equivalent, and two years of directly related experience
Preferred
ACRP or SOCRA Certification
Bilingual (Spanish)
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