Clinical Research Coordinator 1
University of Miami

Miami, Florida

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The Department of Dermatology has an exciting opportunity for a full-time Clinical Research Coordinator to work in Miami, FL. The Clinical Research Coordinator provides professional level support for research clinical studies involving human subjects and assists in the design of studies, generation of databases, and update and maintenance of documentation. Moreover, the Clinical Research Coordinator develops, verifies, and implements procedures to accomplish research goals.

  • Coordinates routine activities of clinical studies including data maintenance, grant expenditure adherence, project evaluation, meeting scheduling, and research subject interfacing.
  • Tracks medical reports and reviews regulatory documents to generate reports.
  • Serves as project liaison to other departments, outside organizations, government agencies, and product representatives.
  • Recruits patients into the study and reviews on a weekly basis the percentage recruited.
  • Reviews data collected and inserts into the study dataset.
  • Compares the data collected to the monitored phone calls for data quality assurance.
  • Evaluates and monitors timelines for studies and for each subject participant to comply with applicable protocols.
  • Prepares materials for the brochures and retaining letters and mails to appropriate members according to their time in the study.
  • Administers informed consent forms for patients on drug studies.
  • Maintains pool of study candidates and ensures their availability.
  • Coordinates the necessary testing for patient evaluations per physicians' orders and study protocol requirements.
  • 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.

MINIMUM QUALIFICATIONS
  • Bachelor's Degree in a relevant field
  • Minimum 3 years of relevant experience
  • Skill in completing assignments accurately and with attention to detail.
  • Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
  • Ability to process and handle confidential information with discretion.
  • Ability to work evenings, nights, and weekends as necessary.
  • Commitment to the University's core values.
  • Ability to work independently and/or in a collaborative environment.

DEPARTMENT SPECIFIC FUNCTION
  • Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational mate
  • rial accountability forms.
  • Create and design appropriate templates as Source Documents for Sponsor Initiated and Investigator initiated Studies.
  • Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
  • Manage coordination of facilities monitoring, auditing visits, site evaluations and Initiation visits.
  • •Maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants.
  • Establishes/maintains contact with patient/participants, health care providers, community agencies and study sponsors.
  • Strong Background in: Patient interactions in clinical trials (phone calls/scheduling), Dermatology clinical trials procedures and Dermatology (wound healing, dermatitis, hair, etc.)

#LI-NN1

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 here for additional information.

Job Status:
Full time

Employee Type:
Staff

Pay Grade:
A8


This job has expired.

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