University of Texas Medical Branch
Study Coordinator - Regulated Studies-ONSITE ONLY
University of Texas Medical Branch, Galveston, Texas, United States, 77554
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.
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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.
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.