Working under general direction and with a high degree of independence, the Data and Regulatory Coordinator will manage the data coordination of complex studies conducted within the Neurological and Behavioral Outcome Center (NBOC). Duties include performing interim data analysis and database preparation for final analyses and ensuring that NBOC is in compliance with all regulatory guidelines and requirements for the conduct of research with human participants.
Design and construct complex databases for statistical analysis and tracking data per study protocols. Independently assess project objectives, and decide on the most efficient and effective way to enter and organize the study data. Determine scoring of rating scales based on research data collection and statistical analysis (SPSS, Excel, REDCap, etc.). Develop appropriate, effective collection methods (paper and electronic) and disseminate changes in protocol as needed. May create a randomization chart (stratified based on relevant variables identified).
Assist in developing better data coordination and management procedures. Coordinate information with others as needed.
Work with external sites regarding data collection and transfer. Be the point person for this site including attending teleconferences and meetings.
Work with data coordinating centers to resolve data discrepancies, including coordinating various staff at this site and providing feedback to the data coordinating center.
Write syntax/code for statistical programs to prepare data sets for analyses. Perform general statistical analysis on collected data. Generate macro syntax templates to facilitate database creation. During database creation and revision, ensure variables requested by the statistical team have been captured requiring in-depth knowledge of all study protocols, assessments, specific aims, and hypotheses to ensure the data being collected by the program will be able to be utilized in the way in which it was intended by the investigators and sponsors.
Oversee quality assurance procedures. Review quantitative and qualitative data entry for inconsistencies. Perform regular data audits and determine what action is required for resolution of data discrepancies. Ensure all resolutions/ audits are complete.
Identify problems with current quality assurance systems. Develop new data quality assurance procedures to enhance the quality of the data.
Train new staff in data procedures.
Responsible for IRB submissions: write/maintain new protocol, amendment, continuing review, and study closure applications, consent/assent forms, adverse event reports, study manuals, and protocol to reflect amendments. Report current enrollment, participant characteristics, and safety information. Perform frequent audits of the regulatory documents and IRB communications for all ongoing studies. Determine and note inconsistencies, collaborate with the research coordinators to resolve any noted findings, and assure compliance. Make recommendations to investigators and research manager as to the best course of action to resolve regulatory issues with regulatory bodies, sponsors, and study team. Gather and review information on unanticipated events and make determinations as to the appropriate methods needed to report to various entities (regulatory bodies, sponsors, etc.). Ensure compliance with essential documentation for various regulatory bodies (e.g., IRB, DSMB, etc.), as required per study protocol. Oversee and develop source documents for various studies.
Provide necessary materials for accurate and timely dissemination of study findings to the research community. Provide expertise when questions of reporting requirements arise. Write and edit sections of reports for sponsors, manuscripts for publication, and slides and poster presentation at scientific conferences as requested by principal investigator and manager.
Provide input and recommendations to the statistical team regarding significant developments in research projects.
Organize data file storage for all current and past studies, including determination of appropriate time to purge records in compliance with CWRU and UHCMC IRB guidelines, and other relevant SOPs.
Assist with literature searches.
Perform other research-related duties as assigned.
Department: Daily contact with: research operations manager, principal/co-investigators, and research assistants. Frequent contact with other department faculty, residents, and staff.
University: Frequent contact with regulatory staff within the UH Center for Clinical Research and Technology. Occasional contact with members of the DSMB.
External: Frequent contact with investigators and study staff at other study sites. Occasional contact with study sponsors and NIH.
Students: Frequent contact with student employees.
May be assigned short-term supervisory responsibilities under the direction of the principal investigator.
Experience: 4 to 5 years of experience coordinating data, preferably in an academic research setting.
Education/licensing: Bachelor’s degree, with working knowledge of statistics. Master’s degree strongly preferred.
Knowledge and understanding of commonly-used concepts, practices, and procedures within the field of neurology/ psychology/ psychiatry.
Knowledge of the intricacies of research protocols.
Understanding of and training/education in statistical analysis, including the ability to perform descriptive and analytic statistical operations independently.
Strong problem solving skills, with the ability to determine and implement necessary data management and quality assurance procedures independently.
Flexibility and willingness to adapt and function in a variety of situations as a team member and leader.
Advanced proficiency in Microsoft Office and SPSS. Experience creating and maintaining complex databases and writing syntax/code.
Experience with regulatory requirements (e.g., IRB, OHRP, etc.).
Experience using REDCap is a plus.
Professional and effective verbal and written communication skills, and good interpersonal skills, with the ability to work and communicate with various individuals within and external to the University.
Strong organization skills, with the ability to organize complex tasks; must demonstrate attention to detail and accuracy and time management skills.
Ability to work effectively independently and collaboratively within a team. Must be highly motivated, responsible, dependable and a self-starter.
Must demonstrate willingness to learn new techniques, procedures, processes, and computer programs as needed.
Knowledge of psychological assessments, DSM-5 diagnosis, and pharmacological treatments of psychiatric disorders preferred.
Typical office environment. The employee will perform repetitive motion using a computer mouse and keyboard to type.