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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.
Core responsibilities:
- 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.
Department Specific Functions:
- 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 performance reports; identifies trial performance issues and implements plans to improve performance.
- Prepares materials for IRB submission; ensures that research teams remain in compliance with IRB requirements.
- Guides and assists local and remote partner sites in completing site selection materials to facilitate their inclusion in new clinical research studies.
- Issues reports of study progress for Investigators and Sponsors.
- Monitors site regulatory files to ensure regulatory compliance.
- Provides mentoring and consultation to research managers at partner sites.
- Manages remote meetings with study teams at partner sites to ensure protocol adherence.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.Core Qualifications:- Bachelor's degree in relevant field required. Master's preferred.
- Minimum 5 years of experience in clinical research.
- Professional Certification in Clinical Research (e.g., ACRP, SOCRA) preferred.
- Knowledge of federal regulations and policies governing clinical research.
- Knowledge of clinical research implementation processes.
- Knowledge of QA/QC Monitoring systems and practices.
- Ability to direct, manage, implement, and evaluate department operations.
- Ability to establish department research goals, and objectives that support the strategic plan.
- Ability to effectively plan, delegate and/or supervise the work of research staff.
- Ability to lead, motivate, develop, and train others.
- Ability to establish and maintain relationships with a network of research partner sites
- Highly organized, goal and action focused, clear communicator
- Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
- Teamwork: Ability to work collaboratively with others and contribute to a team environment.
- Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
- Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
Job Status:Full time
Employee Type:Staff
