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MUSC Health · 5 months ago

UNIV - Program Manager I - Department of PHS

Charleston, SC

Full-time

Onsite

Mid Level

$57K/yr - $106K/yr

3+ years exp

The Medical University of South Carolina (MUSC) is seeking a full-time Program Manager I to oversee the SC ECHO cohort in the Department of Public Health Sciences and the Department of Obstetrics and Gynecology. The role involves managing ECHO project initiatives, ensuring regulatory compliance, and supervising research staff while contributing to the overall execution of clinical research studies.

Health CareHospitalMedical

Responsibilities

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%)

Qualification

Clinical research knowledgeRegulatory complianceParticipant recruitmentBudget managementData collectionTeam supervisionStakeholder managementTraining staffProblem-solving skills

Required

A bachelor's degree and three years relevant program experience

Knowledgeable about clinical research studies

Good problem-solving skills

Ability to define study deliverables and manage to a timeline

Experience in directing workflow and providing feedback to ensure study goals are met

Responsible for budgeting of clinical components of the project

Ability to ensure all budgets and expenditures follow University and Federal guidelines

Experience in tracking and reviewing clinical research billing

Ability to coordinate and implement the ECHO program

Experience in supervising research staff and their training

Knowledge of ICH/GCP guidelines

Ability to oversee regulatory documentation for all IRB submissions and study sponsor

Ability to prepare progress reports for study sponsors

Preferred

Five years' experience related to observational cohort studies

Experience with participant recruitment and community outreach

Familiarity with MUSC's IRB processes and regulatory requirements

Company

MUSC Health

MUSC Health provides health-care services through its patient- and family-centered care, education, research, and various partnerships. It is a sub-organization of Medical University of South Carolina.

Founded in 1824

Charleston, South Carolina, USA

10001+ employees