Sr Clinical Research Monitor - Hybrid
Sr Clinical Research Monitor - Hybrid
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Job Description
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 ResearchMonitoris responsible formonitoring 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) andapplicable regulatoryrequirements.
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 startup 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 Universitys research community.
Monitors new legislation or changes in regulations that might affect the Universitys compliance in conducting research.
Interacts with other departments and external entities to resolve researchrelated 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 unitlevel policies and procedures and safeguards University assets.
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:
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.
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:
A11Required Experience:
Senior IC
Employment Type
Full-Time
