Medical University of South Carolina
UNIV - Program Manager I - Department of PHS
Medical University of South Carolina, Charleston, South Carolina, United States, 29401
Program Manager I
A full-time Program Manager I is needed to continue successful execution and oversight of our SC ECHO cohort in the Department of Public Health Sciences and the Department of Obstetrics and Gynecology. This position will include co-directing and managing ECHO project initiatives and research studies by overseeing and contributing to program design, implementation, and daily administrative activities. This role combines direct clinical-research interface with strategic program oversight. The Program Manager will be responsible for maintaining regulatory requirements, enrollment, study procedures, data collection and management, and supervision of team members. The Program Manager will also be responsible for contributing to the daily activities of the study including recruitment of study participants, conducting study visits, processing samples, maintaining stakeholder relationships, and training staff to perform these activities. The Program Manager will work with clinicians, patients, families, and researchers in the clinical setting and interact with the national ECHO Coordinating Center, the national ECHO Data Center, and the national ECHO Biorepository. Job Duties: Responsible for defining study deliverables, contributing to study deliverables, and managing to a timeline. This requires that the Program Manager is knowledgeable about clinical research studies. Also requires good problem-solving skills and how to ensure goals and timelines are met. Meets with study PIs weekly to discuss deliverables for the study and clinical program and solutions to address any needed changes. (30%) Directing workflow, participating in workflow, and providing feedback to team to ensure study goals are met including screening, recruitment, enrollment, data collection, retention and community outreach for the study. Ensures study recruitment is on track and problem solves on how to improve recruitment efforts if needed. (25%) 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 insure this is on track. (15%) Co-lead the coordination and implementation of the ECHO program at MUSC. Coordinate 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 start-up meetings (sponsor and internal). (10%) Supervision of research staff and 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. (10%) 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. (10%) MUSC Minimum Training and Experience Requirements: A bachelor's degree and three years relevant program experience. Preferred Qualifications: Five years' experience related to observational cohort studies, experience with participant recruitment and community outreach, and familiarity with MUSC's IRB processes and regulatory requirements.
A full-time Program Manager I is needed to continue successful execution and oversight of our SC ECHO cohort in the Department of Public Health Sciences and the Department of Obstetrics and Gynecology. This position will include co-directing and managing ECHO project initiatives and research studies by overseeing and contributing to program design, implementation, and daily administrative activities. This role combines direct clinical-research interface with strategic program oversight. The Program Manager will be responsible for maintaining regulatory requirements, enrollment, study procedures, data collection and management, and supervision of team members. The Program Manager will also be responsible for contributing to the daily activities of the study including recruitment of study participants, conducting study visits, processing samples, maintaining stakeholder relationships, and training staff to perform these activities. The Program Manager will work with clinicians, patients, families, and researchers in the clinical setting and interact with the national ECHO Coordinating Center, the national ECHO Data Center, and the national ECHO Biorepository. Job Duties: Responsible for defining study deliverables, contributing to study deliverables, and managing to a timeline. This requires that the Program Manager is knowledgeable about clinical research studies. Also requires good problem-solving skills and how to ensure goals and timelines are met. Meets with study PIs weekly to discuss deliverables for the study and clinical program and solutions to address any needed changes. (30%) Directing workflow, participating in workflow, and providing feedback to team to ensure study goals are met including screening, recruitment, enrollment, data collection, retention and community outreach for the study. Ensures study recruitment is on track and problem solves on how to improve recruitment efforts if needed. (25%) 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 insure this is on track. (15%) Co-lead the coordination and implementation of the ECHO program at MUSC. Coordinate 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 start-up meetings (sponsor and internal). (10%) Supervision of research staff and 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. (10%) 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. (10%) MUSC Minimum Training and Experience Requirements: A bachelor's degree and three years relevant program experience. Preferred Qualifications: Five years' experience related to observational cohort studies, experience with participant recruitment and community outreach, and familiarity with MUSC's IRB processes and regulatory requirements.