UNIV - Program Manager II - ECHO - Department of PHS

Medical University of South Carolina • Charleston, SC

2d

About The Position

A full-time Program Manager II is needed to lead the SC ECHO cohort within the Department of Public Health Sciences and the Department of Obstetrics and Gynecology. This position will direct and manage ECHO project initiatives and research studies by overseeing and contributing to program design, implementation, and daily administrative activities, as well as tracking study metrics and working closely with PI to provide comprehensive guidance to address needed changes. The Program Manager will also work closely with clinicians, patients, families, and researchers in clinical settings and assist in continuing to build and support the SC ECHO project. The Program Manager will serve as a primary liaison within the national ECHO Coordinating Center, ECHO Data Center, and ECHO Biorepository. Responsibilities include overseeing program development, ensuring regulatory compliance, hiring, training, and supervising study staff, conducting quality assurance of staff activities, and managing data collection and data management activities for SC ECHO initiatives. The Program Manager will lead and serve as a member in multiple national committees and task forces and assist with facilitating group discussions and report-back sessions at national ECHO meetings. The Program Manager will also actively contribute to daily study operations, including participant recruitment and conduct of study visits.

Requirements

• A bachelor's degree and four years relevant program experience.

Responsibilities

• Directs and supports study workflows and provides ongoing feedback to team to ensure achievement of study goals across screening, recruitment, enrollment, data collection, biospecimen collection and processing, retention, and community outreach for the study. Monitors recruitment and performance metrics and implements problem-solving strategies to improve recruitment, retention, and study visit outcomes as needed.
• Define and contribute to study deliverables; manages project timelines and tracks study performance metrics. Demonstrates strong knowledge of clinical research and effective problem-solving skills to ensure milestones are achieved. Collaborates closely with study PIs to determine deliverables for the study and clinical program and provides comprehensive guidance to implement required changes.
• Hire, mentor, and supervise a growing team of research staff, manage their outputs, and oversee their training according to National ECHO Guidelines. Responsible for education and training of staff on ICH/GCP guidelines, training pertaining to ECHO MOP implementation, as well as MUSC research policy and procedures. Ensure all ECHO protocol requirements are being adhered to at MUSC. Conduct quality assurance of study staff activities. Provide direction and strategies to overcome barriers of the study.
• Oversee regulatory documentation for all IRB submissions and study sponsor. Design, direct and execute regulatory and budgetary documentation. Oversee reporting and communications for programmatic and scientific review by applying processes, methods, knowledge, and skills to support successful program initiation, execution, and quality control. Hold primary responsibility for processing IRB submissions, amendments, and annual reports for the MUSC clinical site with the sIRB WCG. Prepare progress reports for study sponsors. Develop and maintain study specific documents, including ICFs, SOPs, and participant recruitment and learning materials.
• Lead the coordination and implementation of the ECHO program at MUSC. Work closely with the ECHO National Coordinating Center, the ECHO National Data Center and the ECHO National Biorepository to implement their policies and procedures at MUSC. Design, direct and lead collaborative efforts across MUSC by serving as liaison with MUSC Departments of Public Health Sciences, Obstetrics & Gynecology and Pediatrics and the broader national ECHO consortium. Facilitate and present at internal and NIH meetings, co-lead national ECHO age band pod group, and serve as a member on ECHO committees.
• Responsible for the budgeting of the clinical components of the project. Ensure all budgets and expenditures follow University and Federal guidelines. Responsible for the tracking and review of all clinical research billing from SC ECHO participants. Must ensure all charges are appropriately identified as research or standard of care, and responsible for the resolution of all billing issues. Review study budgets with study PIs to ensure this is on track.
• Direct data quality monitoring and cleaning.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level