Sr. Project Manager, Research Support

University of Miami•Miami, FL

6d•Onsite

About The Position

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. This role oversees multiple related projects to ensure the overall program is aligned to, and directly in support of, institutional objectives. It involves preparing reports, establishing practices and policies, preparing project plans, procuring resources, monitoring staff performance, managing quality control, and ensuring projects proceed according to schedule with quality standards. The position also establishes and assesses internal controls, ensures employee training on controls and university policies, and aids in evaluating workflow and planning issues. It implements approved protocols and operational plans consistent with strategic business objectives and adheres to University policies and procedures, safeguarding University assets.

Requirements

Bachelor’s degree in relevant field required.
Minimum 5 years of experience in clinical research.
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.

Nice To Haves

Master's preferred.
Professional Certification in Clinical Research (e.g., ACRP, SOCRA) preferred.

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.
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.
Manages 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.