Manager Clinical Research Monitoring
Manager Clinical Research Monitoring
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Job Description
Current Employees:
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The Department of Executive Dean For Research is currently seeking a full time Manager Clinical Research Monitoring to work in Miami. The Manager Clinical Research Monitoring oversees a team of University of Miami clinical research monitors for investigational site monitoring of clinical trials. This role ensures training and mentoring of all clinical research monitors.
CORE JOB FUNCTIONS
Oversees a team providing regulatory support for clinical research studies supported by the department.
Identifies study issues and implements solutions including identifying and involving the appropriate decisionmakers.
Anticipates regulatory needs and implements tools for effective study management.
Assists in creation and management of reports.
Facilitates the development of site training documentation and materials.
Assists in the creation or revision and maintenance of standard operating procedures and work instructions.
Contributes to the development and writing of protocols and other study documents for clinical research studies.
Monitors new legislation or changes in regulations that might affect the Universitys compliance in conducting research provides guidance and recommends changes to administrative policies and procedures.
Maintains records of regulatory activities and prepares reports responses and followup activities.
Provides expert consultation on regulatory issues to research sites and investigators.
Advises appropriate institutional officials of deficiencies and recommends necessary corrective actions with followup to ensure that needed actions have been implemented.
Assists with internal and external audit preparations.
Remains in compliance with federal state and local regulations and extramural agencies requirements.
Assists with the preparation and presentation of educational programs to groups and individuals in the University research community.
Provides regulatory guidance to principal investigators and research teams.
Maintains regulatory support related databases and files.
Assists with the preparation of quarterly reports of regulatory activities summarizing efforts taken and changes to be implemented at both University and department levels.
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.
This list of duties and responsibilities is not intended to be allinclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
Education:
Bachelors degree in relevant field.
Certification and Licensing:
Clinical research certification e.g.ACRP SOCRA)
Experience:
Minimum 5 years of experience with clinical trials (involving biologics or devices) required.
Knowledge Skills and Attitudes:
Strong knowledge of researchrelated federal regulations (FDA and HHS) guidance documents and state laws
Good Clinical Practice (GCP) FDA regulatory requirements and ICHGCP guidelines
Excellent English skills both verbal and written
Excellent interpersonal and team skills
Strong attention to detail time/project management and organization skills
Strong Microsoft Office (Excel Outlook PowerPoint Word) skills
Ability to meet deadlines prioritize tasks and works well both independently and as a team
Ability to managemultiple projectsand assignments
Excellent customer service skills.
DEPARTMENT ADDENDUM
Department Specific Functions
Manages and coordinates clinical research monitoring resources and workload for studies requiring or requesting regulatory oversight.
Assists with defining departmental monitoring processes strategies and goals.
Oversees management of multiple investigational studies.
Provides interpretation and implementation of new regulations or guidance related to monitoring.
Escalates any ongoingissues identified from routine monitoring visits to the Director.
Collaborates with Data & Safety Monitoring Boards or Committees.
Works with Research IT to visualize data related to how studies are monitored including reports of queries issued in institutional CTMS and EDC systems.
Implements and maintains a billing and data tracking structure for monitoring services to recover costs for applicable clinical trials.
Reviews and approves the creation and revision of monitoring plans and oversees adherence to them.
In collaboration with the Research Quality Assurance team and study teams assists with external audit preparation activities for studies monitored by IITSU.
Implements and maintains a rate sheet for monitoring services.
Creates cost estimates for departments requiring or requesting monitoring services.
Develops maintains and oversees training matrix for monitors.
Makes recommendations on corrective and preventive action (CAPA) plans for studies being monitored IITSU and refers to RQA for implementation.
Conducts or assists with prestudy visits site initiation visits routine monitoring visits and closeout visits as needed.
Other duties as assigned.
The University of Miami offers competitive salaries and a comprehensive benefits package including medical dental tuition remission and more.
UHealthUniversity of Miami Health System South Floridas only universitybased health system provides leadingedge 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 subspecialties 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. Were the challenge youve been looking for.
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 here for additional information.
Job Status:
Full timeEmployee Type:
StaffPay Grade:
A13Required Experience:
Manager
Employment Type
Full-Time
