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The Sylvester Comprehensive Cancer Center has an exciting opportunity for a full-time Clinical Research Coordinator 1 to work on the UHealth Campus. 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.

• Performs recruitment procedures including informed consent process and ensures eligibility forms are completed as requires.

• Establishes and maintains contact with patients/participants, health care providers, community agencies, study sponsors.

• Execute the plan developed for collection and tracking of protocol specific subject specimens, i.e. blood specimen, tissue samples, etc. as per protocol.

• Ensures study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents while obtaining relevant medical information from patient clinic charts/medical records.

• Provides protocol specific study documentation required in the management of study patients as per the protocol, federal regulations, sponsor requirements, SOPs and UM policies while maintaining logs to track progress reports to both currently enrolled as well as follow-up participants.

• Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.

• Enters data onto case report forms and/or into computer database.

• Reviews consent forms, sample collection tracking forms and clinical data to ensure information obtained is accurate and complete and will address any data inconsistencies to correct data issues in a timely manner.

• Takes action to report and correct deviations or other problems. Records and reports AEs in compliance with federal regulations, the protocol and UM policies to the sponsor and/or IRB as directed by the PI.

Department Specifics:

• Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
• Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
• Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
• Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
• Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
• Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
• Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
• Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
• Knows the contents and maintenance of study-specific clinical research regulatory binders.
• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• 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 relevant field required

• Minimum 1 year of relevant experience

KSA:

• 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.

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.

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