• Sr. Clinical Research Monitor - Hybrid

    University of Miami (Miami, FL)


    Current Employees:

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    The Office of the Executive Dean for Research at the University of Miami Miller School of Medicine has an opening for a Sr. Clinical Research Monitor. The Sr. Clinical Research Monitor is responsible for monitoring the progress of assigned Investigator- initiated clinical trials to ensure studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP) and applicable regulatory requirements.

    CORE JOB FUNCTIONS

    + Oversees clinical study sites to assure activities are in adherence with Good Clinical Practices (GCPs), federal regulations, standard operating procedures, and study protocols.

    + Reviews regulatory documents and prepares site visit reports.

    + Assists with study development and start-up processes, including reviewing protocols, and preparing informed consent forms.

    + Participates in clinical training programs and maintains awareness of developments in the field.

    + Evaluates quality and completeness of data and participants’ safety documentation.

    + Provides consultation on quality control and assurance issues to research sites and investigators.

    + Generates monitoring reports of findings, and tracks correction efforts.

    + Assists the preparation and presentation of educational programs to the University’s research community.

    + Monitors new legislation or changes in regulations that might affect the University's compliance in conducting research.

    + Interacts with other departments and external entities to resolve research-related problems.

    + Helps with the creation and maintenance of policy and procedure manuals intended to assist University researchers in maintaining compliance with research standards and guidelines. Provides regulatory support to principal investigators and research teams.

    + Provides assistance in the maintenance of a corrective action preventive action system.

    + Maintains databases, and electronic and paper audit files.

    + Assists with internal and external audit preparation.

    + Assists with the training and mentoring of new clinical research associates.

    + 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

    Certification and Licensing:

    ACRP or SOCRA Certification

    Experience:

    Minimum 3 years of relevant experience

    Knowledge, Skills and Attitudes:

    + Ability to maintain effective interpersonal relationships

    + Ability to communicate effectively in both oral and written form

    + Skill in collecting, organizing and analyzing data

    + Proficiency in computer software (i.e. Microsoft Office)

     

    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 - 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 (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information.

    Job Status:

    Full time

    Employee Type:

    Staff

    Pay Grade:

    A11