Manage multiple large-scale research studies for the Chairman of Pediatrics. These include but are not limited to NIH and pharmaceutical studies.
Lead and manage the grant and project efforts to perform all projects related activities according to project milestones/deliverables/budget in a manner consistent with the stated project timelines and deliverables.
Maintain the administrative coordination of all protocols, operation manuals and study forms. Ensure quality control of the study data: core facilities and the research enrollment and procedures at the participating sites.
IRB compliance, regulatory oversight and submissions including remote monitoring of the site study and regulatory materials.
Oversee the data collection process and summary reports, data entry and query resolution and data analysis. Coordination between the coordinating centers and the participating sites.
Coordinate multi-author scientific manuscripts and manage writing groups
This position facilitates communication between study investigators, the NIH and other sponsors and coordinating centers. This includes the training of the site study staff. You will serve as primary liaison to study investigators and study sites. Troubleshooting resolution of any issues that may arise throughout the studies/projects is ongoing and requires rapid response, discretion, and discernment of Chairman's priorities.
You will communicate on-going project status, budget, potential issues, and timelines to Chairman, Principal Research Specialist and other principal investigator(s) and be able to discuss/summarize the cultivation of any identified opportunities, challenges and solutions to the successful completion of the project. The position also supports administrative management of study's biorepository with the assistance of the UB Biorepository team.
As an Equal Opportunity / Affirmative Action employer, the Research Foundation will not discriminate in its employment practices due to an applicant's race, color, religion, sex, sexual orientation, gender identity, national origin and veteran or disability status.
Bachelor's degree required and 3 or more years' experience in academic medical center research operations and coordination, understanding of managing NIH/Pharm studies. Previous experience with complex communications and coordination environments. Knowledge of Human Subjects Research and IRBs, Excellent communication and organizational skills. Proficiency in Microsoft Office and EndNote. Motivated team-based worker with ability for independent direction when needed. Accommodating disposition and comfort with fast-paced, ever-changing environment and a large range of contacts.
Master's degree preferred. Previous experience in pediatric clinical in pediatric federal research preferred demonstrating communication, organization and time management skills. Scientific manuscript writing/editing/submission experience. Some knowledge of budget development. Some travel availability. Experience in basic clinical research and database management. Grant writing experience.
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