Manager, Clinical Research

University of Miami•Miami, FL

2d•Onsite

About The Position

The Clinical Translational Research Site is currently seeking a full time Manager, Clinical Research to work in Miami. The Manager, Clinical Research (A) 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 JOB FUNCTIONS 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. Tracks proposals and other study relevant documentation through signature/approval processes then through collaboration with Contracts and budgets. Serves as liaison and facilitates meetings between project stakeholders and leadership and completes and maintains professional documentation for projects and deliverables, develops SOPs as needed, and assists in the auditing and monitoring of studies. Identifies areas for improvement within daily functions, internal procedures, and regulatory agency interactions. Interacts with project team members to define submission logistics and workflow scheduling. Oversees the ongoing maintenance of records detailing the number of active INDs and IDEs and related data via an internal tracking system. Prepares and presents the annual summary report for clinical trial and research areas. Provides consultation and guidance for UM held INDs and IDEs. 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 Develops and oversees the financial operations of study coordinator service lines for CTRS/ MSOM investigators, encompassing regulatory and study management services for clinical research trials. Assists with developing initiatives to transform processes within the CTRS to enhance the clinical research enterprise. Participates in the design and execution of program improvement plans derived from annual evaluations of the clinical coordinator services of the CTRS. Promotes visibility/availability of the CTRS coordinator services throughout the institution. Helps to develop and operationalize clinical research coordinator services in the UHealth system. Ensures proper budgeting, invoicing, and payment for all individual study activities conducted by clinical research coordinators. Participates in human resources activities for direct reports, including recruiting and selection, hiring and termination, training, development, mentoring, counseling, performance evaluations, and providing recommendations to CTRS leadership. Conduct meetings with research staff and ensure functions are coordinated promptly and accurately. Responsible for the design, execution, and effectiveness of a system of internal controls that provides reasonable assurance that operations are effective and efficient, assets are safeguarded, and financial information is reliable and compliant with applicable laws, regulations, policies, and procedures. Develop and maintain a set of metrics to drive the decision-making process for CTRS needs and track productivity. Analyzes reports, data briefs, and auxiliary publications for new topic modules. Participate in relevant committees to provide clinical research expertise and guidance. Establishes and continuously assesses the effectiveness of the SOPs within the CTRS and compliance with university policies and procedures. Performs other duties as assigned. 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.

Requirements

Master’s degree in relevant field preferred.
SOCRA or ACRP certification is required.
Five (5) years of experience managing an extensive clinical research program or project is required.
This position is onsite.
Exceptional leadership and communication skills with experience in clinical research development.
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.

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.
Tracks proposals and other study relevant documentation through signature/approval processes then through collaboration with Contracts and budgets.
Serves as liaison and facilitates meetings between project stakeholders and leadership and completes and maintains professional documentation for projects and deliverables, develops SOPs as needed, and assists in the auditing and monitoring of studies.
Identifies areas for improvement within daily functions, internal procedures, and regulatory agency interactions.
Interacts with project team members to define submission logistics and workflow scheduling.
Oversees the ongoing maintenance of records detailing the number of active INDs and IDEs and related data via an internal tracking system.
Prepares and presents the annual summary report for clinical trial and research areas.
Provides consultation and guidance for UM held INDs and IDEs.
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.
Develops and oversees the financial operations of study coordinator service lines for CTRS/ MSOM investigators, encompassing regulatory and study management services for clinical research trials.
Assists with developing initiatives to transform processes within the CTRS to enhance the clinical research enterprise.
Participates in the design and execution of program improvement plans derived from annual evaluations of the clinical coordinator services of the CTRS.
Promotes visibility/availability of the CTRS coordinator services throughout the institution.
Helps to develop and operationalize clinical research coordinator services in the UHealth system.
Ensures proper budgeting, invoicing, and payment for all individual study activities conducted by clinical research coordinators.
Participates in human resources activities for direct reports, including recruiting and selection, hiring and termination, training, development, mentoring, counseling, performance evaluations, and providing recommendations to CTRS leadership.
Conduct meetings with research staff and ensure functions are coordinated promptly and accurately.
Responsible for the design, execution, and effectiveness of a system of internal controls that provides reasonable assurance that operations are effective and efficient, assets are safeguarded, and financial information is reliable and compliant with applicable laws, regulations, policies, and procedures.
Develop and maintain a set of metrics to drive the decision-making process for CTRS needs and track productivity.
Analyzes reports, data briefs, and auxiliary publications for new topic modules.
Participate in relevant committees to provide clinical research expertise and guidance.
Establishes and continuously assesses the effectiveness of the SOPs within the CTRS and compliance with university policies and procedures.
Performs other duties as assigned.