Sr. Project Manager, Research Support

The University of Miami/UHealth Department of Public Health has an exciting opportunity for a full time Sr. Project Manager, Research Support to work in Miami, FL.

• Oversees multiple related projects to ensure the overall program is aligned to, and directly in support of, institutional objectives.
• Prepares reports regarding project status and activities.
• Establishes practices, policies, and partnerships to effectively carry out functions.
• Prepares estimates and detailed project plans for all phases.
• Procures adequate resources to achieve project objectives in established timeframe.
• Monitors staff performance and completes performance reviews.
• Manages ongoing quality control and participates in quality issue resolution.
• Ensures that projects and programs are proceeding according to schedule with quality standards.
• Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with university policies and procedures.
• Ensures employees are trained on controls within the function and on university policy and procedures.
• Aids in the evaluation of problems with workflow, organization, and planning and develops appropriate analytical approaches.
• Implements approved protocols and operational plans, which are consistent with strategic business objectives.
• Adheres to University and unit-level policies and procedures and safeguards University assets.

• Manages every aspect of the implementation of complex clinical research studies.
• Ensures compliance with the research protocol, Manual of Operations, Safety Monitoring Plan, Local SOP's, Good Clinical Practices, and Federal Research Regulations.
• Oversees the research activities of study staff including research assistants, coordinators, outreach staff, and study phlebotomists.
• Establishes effective communication procedures among study team members.
• Oversees the activities of a team of Clinical Research Quality Assurance Monitors.
• Provides leadership, guidance and support to the Monitoring Team, ensuring that Monitors are complying with each study's QA Monitoring Plans and all applicable Institutional and Federal Research Regulations.
• Manages the weekly meetings of the department Quality Assurance (QA) Team for clinical research studies
• Reviews and approves Clinical Research QA Monitoring Reports before reports are sent to Principal Investigators.
• Responds promptly to problems and concerns reported by study staff, applying problem-solving and critical thinking to make decisions and resolve issues.
• Reviews, approves, and enforces standard operating procedures for the implementation clinical trials to ensure regulatory compliance and standardization of procedures.
• Conducts resource needs assessments for research projects and ensures needed resources are in place for daily operations.
• This includes managing the sites' supply of participant incentives/compensation for various studies and establishing procedures to maintain adequate supply of study related supplies/equipment.
• Develops and provides training to research teams on study procedures, including informed consent, research assessments, screening/eligibility, good documentation practices, quality control and assurance practices, and safety monitoring.
• Provides retraining as needed to maintain high data quality and protocol compliance.
• Builds and maintains relationships with a network of community organizations which refer and/or provide collateral services to study participants.
• Coordinates community outreach activities to recruit and retain participants with a myriad of risk factors including homelessness, mental health issues, substance abuse, and other related health issues.
• Manages team meetings of Site Principal Investigators, Study Physicians, Research Assistants, Outreach Workers and QA Monitors to ensure adequate study progress; provides task assignments to each study team member.
• Conducts remote and onsite monitoring of clinical trials, including FDA-regulated trials, tracks findings to resolution, and prepares formal monitoring reports for PI's and Sponsors, ensuring adherence to the study protocol and all applicable federal research regulations.
• Guides site research teams in addressing implementation challenges, such as barriers to participant recruitment, and developing corrective action plans to address any performance deficiencies.
• Monitors study site performance (i.e., recruitment, retention, data quality, etc.) and prepares and disseminates site…