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.