Project Manager, Clinical Research

University of Miami; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Tuition remission

Job summary

The University of Miami is seeking a Project Manager, Clinical Research to oversee planning and management of clinical trials and research projects, coordinating regulatory-related decisions and resources for investigators and teams.

This role emphasizes quality service, research reviews, program management, and collaboration to advance education and patient care within UHealth and the Miller School of Medicine.

Qualifications

• Bachelor’s degree in relevant field required.
• Minimum five years of relevant experience.
• Learning agility to adapt to procedures, technologies, and priorities.
• Strong teamwork and collaboration across teams.
• Effective communication, both written and verbal, with stakeholders.
• Proficiency with office software and institutional research tools.

Responsibilities

• Defines project scope with leadership and sets measurable success criteria.
• Allocates resources and creates detailed project plans and timelines.
• Monitors progress and adjusts schedules to ensure on-time delivery.
• Identifies protocol issues and assists in resolution with investigators.
• Coordinates staff selection and assigns tasks to project team.
• Ensures staff onboarding and orientation aligned with projects.
• Manages project personnel following organizational policies.
• Reviews work quality to meet project standards and maintains records.
• Prepares status reports and presentations for leadership.
• Oversees budgeting and financial tracking related to projects.

Skills

Learning agility

Teamwork

Technical proficiency

Communication

Education

Bachelor's degree in relevant field

Minimum five years of relevant experience

Job description

CORE SUMMARY

The Project Manager, Clinical Research, oversees the planning and management of clinical trials and research projects that support the overall mission of the University. The Project Manager, Clinical Research, manages the execution of regulatory-related decisions/strategies; and coordinates central resource services for principal investigators and other relevant team members. The incumbent promotes clinical research by providing quality services related to research reviews, advanced assessments, research program management and educational functions, and by applying a solution-based, collaborative approach with the goal of continuous quality.

CORE RESPONSIBILITIES

1. Defines the scope of projects in conjunction with leadership and discusses the objectives and measures upon which the project will be evaluated at its completion.
2. Determines the resources required to complete each project and establishes and records comprehensive project plans and timelines, which identify and sequences the activities needed to successfully complete projects.
3. Reviews project schedules with leadership and other staff that will be affected by the project activities.
4. Monitors the progress of the projects and makes adjustments to ensure successful completion.
5. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
6. Consults with the appropriate leadership on the selection of staff to assist with projects.
7. Assigns project task to the identified project team for handling.
8. Ensures all project personnel receive orientation that is appropriate to the project.
9. Manages project staff according to the established policies and practices of the organization.
10. Reviews the quality of work completed with the project team on a regular basis to ensure that work produced meets project standards.
11. Documents all project-related activities and ensures project files are maintained and secured accordingly.
12. Creates a communication schedule to update stakeholders, including appropriate staff in the organization on the progress of projects.
13. Prepares presentations and presents status reports for leadership.
14. Participates in preparation and management of research budgets and monetary disbursements and tracks items related to CDAs, budget and contract completion status.
15. Adheres to University and unit-level policies and procedures and safeguards University assets. 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

• Education: Bachelor’s degree in relevant field required
• Experience: Minimum five years of relevant experience
• Knowledge, Skills and Attitudes: 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.

Department Specific Functions

Oversee and provide support for the process of expanded access/compassionate use submissions (initial, annual, safety reporting [as applicable]) and regulatory document maintenance; serves as point of contact to internal and external stakeholders (e.g., PI, committee(s), regulatory authorities). Submit or assist in the submission of non-emergency and/or emergency use expanded access/compassionate use requests. Send decision correspondence to appropriate parties and request additional information as needed. Maintain current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adhere to university and department-level policies and procedures while safeguarding University assets. Ensure compliance of expanded access/compassionate use processes with institutional SOPs, FDA, NIH, and other applicable regulations. Coordinate all submissions related to expanded access/compassionate use requests (single- and multi-patient) to applicable stakeholders, including but not limited to: PRMC, IRB, Office of Research Administration (ORA), other departments within University of Miami/Sylvester, ancillary committees, and U.S. Food and Drug Administration (FDA). Oversee accurate and timely processing, tracking, and filing of submissions and other pertinent documents within institution’s electronic systems (e.g., Velos, IBIS) and appropriate drives as applicable. Ensure proper document management/recordkeeping for all expanded access/compassionate use projects. For multi-patient expanded access/compassionate use requests, preparation and maintenance of regulatory binders (paper or electronic) may be required. For multi-patient expanded access/compassionate use requests: communicate with staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL) when a DOAL is warranted. Ensure in conjunction with the DOAL that all subsequent training (whether initial or with an amendment/modification) is completed for all personnel and documentation maintained. Assist the Sylvester Investigator and/or staff with accurate reporting of adverse events, including those reported by expanded access/compassionate use participants in accordance with regulatory requirements. Support the investigator and clinical staff with extraction of clinical data from electronic medical records and other sources to ensure proper reporting to the appropriate stakeholders (e.g., sponsor/manufacturer, IRB, FDA). Provide guidance to Sylvester investigators and staff related to expanded access/compassionate use requests, including but not limited to emergency use/non-emergency requests, FDA review and approval process, required committee reviews, internal workflows, etc. Facilitate cooperation between cross-functional teams regarding expanded access/compassionate use activities.

#LI-YC1

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine.

As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status: Full time Employee Type: Staff

The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation. The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride. The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019. The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022. With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.