Clinical Research Manager

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The University of Miami / UHealth Department of Medicine, Division of Infectious Diseases has an exciting opportunity for a Full Time Clinical Research Manager to work in the UHealth Campus.

Core Job Summary :

The Manager, Clinical Research oversees the development of clinical trials and research programs that support the overall mission of the University.

This role is also responsible for the independent execution of regulatory-related decisions / strategies; and coordinates work with Study Managers and other relevant team members to assure the fidelity of study protocols and data collection.

Core Responsibilities :

• Works with investigators and study teams to help meet targets and milestones, ensures timely and accurate submission to IRBs, sponsors and master agreements, and coordinates with the Research Program Director on remediation.
• Coordinates the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as well as exemption requests.
• Assembles project plans, team and work assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately.
• Manages investigator relationships. Maintains IND and IDE documentation, including annual reports for delegated studies and works with the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA.
• Develops, implements, maintains and oversees internal policies and SOPs as well as University wide policies and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best Practices.
• 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.

Department Specific Functions :

• Oversee all CFAR Population Engagement Core research study requests for services.
• Manage clinical research coordinators and research assistants and provide support to faculty. Develop Population Engagement Core SOPs for the creation of a service center.
• Assist in the development of research study protocols. Maintain regulatory compliance for all CFAR Population Engagement studies.
• Coordinate with other CFAR cores to ensure seamless integration of research services.
• Monitor and report on the progress of Population Engagement Core projects.
• Facilitate training and development programs for staff to enhance research capabilities.
• Collaborate with external partners and stakeholders to promote CFAR research initiatives.

CORE QUALIFICATIONS :

Master’s degree in relevant field

Minimum 5 years of relevant experience

Knowledge, Skills and Attitudes :

• Knowledge of business and management principles.
• Ability to direct, manage, implement, and evaluate department operations.
• Ability to establish department goals, and objectives that support the strategic plan.
• Ability to effectively plan, delegate and / or supervise the work of others.
• Ability to lead, motivate, develop, and train others.

LI-EL1

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.

Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination.

Failure to meet this requirement will result in rescinding or termination of employment.

The University of Miami is an Equal Opportunity Employer - Females / Minorities / Protected Veterans / Individuals with Disabilities are encouraged to apply.

Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click for additional information.

Job Status : Full time

Full time

Employee Type : Staff

Staff

Pay Grade :