Study Coordinator – Regulated Studies-ONSITE ONLY

ESSENTIAL JOB FUNCTIONS:
The onsite (at UTMB Galveston main campus) Study Coordinator – Regulated Studies is responsible for assisting the Study Director with all aspects of the study, including pre-study, in-life, and reporting phases of a study. This position will join a staff of highly trained scientists and technicians to support regulated preclinical studies investigating medical countermeasures against viral pathogens. 

This position coordinates and completes the day-to-day administrative activities involved in regulated study design and assists with the scientific and regulatory conduct of a study and reporting of results.  The Study Coordinator – Regulated Studies serves as the project coordinator for multiple research projects under the direction of the Study Director. 

•    Responsible for assisting in the management of all aspects of the studies, including data quality and integrity, efficiency, and regulatory compliance in the execution of study protocols. 
•    Uses MS Project to maintain study schedule.
•    Assist with SOP/protocol/amendment development and IACUC submission.
•    Study start preparation, including animal order requests, request for resources, study calendar preparation, and scheduling pre-study meetings. 
•    Prepare study specific in-life forms, labels, and memos.
•    Extracts and analyzes data for completeness and quality. 
•    Monitors study compliance and maintains a system of effective data flow as defined in the study protocols; Serves as a bridge between Quality Control/Quality Assurance (QC/QA) and the Study Director. 
•    Develops, coordinates, and reviews research study procedures to ensure receipt, completeness, and accuracy of research data required for studies.
•    Ensures study documents are complete and stored appropriately.
•    Participates in data retrieval, reporting, and preparation of files and report forms for various aspects of studies as well as entering data into databases.
•    Responsible for assisting the Study Director in the reporting of protocol/ SOP deviations and responding to Study Audits and QC/QA findings.
•    Participates in study team activities such as project meetings, communications, report generation, etc. 
•    Assists in the development and preparation of study reports including tables and figures.
•    Performs proofreading and QC on study reports. 
•    Assist in the writing of research proposals including grant applications.
•    Adheres to internal controls and reporting structure.

Marginal or Periodic Functions: 
•    Performs related duties as required

MINIMUM QUALIFICATIONS:
•    Bachelor’s degree in related field.

PREFERRED QUALIFICATIONS:
•    M.S.  in Biological Sciences or related field
•    One year experience in research-related administrative support 
•    Experience with quantitative data collection and analysis
•    Strong quantitative analytical skills and evaluation methods.
•    Strong project management skills and excellent written and verbal communication skills.
•    Effective communicator, proactive problem-solver, attention to detail.
•    Skilled organizer for multi-faceted and multi-tasked projects.
•    Adaptable to changing priorities.
•    High degree of professionalism using diplomacy and good judgment.
•    Demonstrated initiative and follow through.
•    Proficient with MS Office Suite, Adobe, Graphing Programs (e.g., GraphPad, SigmaPlot).

SALARY:
Commensurate with experience.