Clinical Research Coordinator 1

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The University of Miami UHealth Department of Urology has an exciting opportunity for a full time Clinical Research Coordinator 1 to work at Don Soffer Clinical Research Center.

The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties, and assumes responsibility for simple clinical research protocols and timelines.

• 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.

Bachelor’s degree in relevant field

Minimum 1 year 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.
• Bilingual in English and Spanish preferred

Any relevant education, certifications and/or work experience may be considered

Clinical Research Coordinator 1 FTE would be delegated to support DSUI clinical studies. Project-specific duties would include:

• Performs screening/recruitment, obtains informed consent process and completes eligibility verification for applicable studies.
• Establishes and maintains communication with study participants, inter- and intra- departmental study team members, health care providers, sponsors and regulatory entities.
• Ensures study protocol adherence, including completion of protocol specific procedures and documentation.
• Maintains screening, enrollment, deviation, delegation of authority and other sponsor and/or protocol specific logs.
• Enters data onto case report forms and electronic data capture systems in accordance with ALCOA-C+ principles.
• Collects, processes, ships and tracks biological specimens following study protocol and regulatory guidelines.
• Reviews consent forms, sample collection tracking forms and clinical data to ensure quality and accuracy.
• Addresses data inconsistencies and provides responses to queries in a timely manner.
• Maintains inventory of study supplies and procures collection kits/supplies in anticipation of future needs.
• Attends research meetings with investigators, study team and site disease group; participates in scientific and clinical discussions relevant to the studies supported.