Clinical Research Coordinator 1 (A)
University of Miami

Job Info

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The department of Psychiatry has an exciting opportunity for a Clinical Research Coordinator 1 to work onsite on the UHealth campus. 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.

CORE JOB FUNCTIONS

• 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.

CORE QUALIFICATIONS

• Bachelor's degree in relevant field
• Minimum 1 year of relevant experience required; 3 years of relevant experience preferred

Knowledge, Skills and Attitudes:

• 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 Functions

• Engage in basic project coordination which include developing project goals, submitting IRB documents and all compliance documents
• Assist with development of scientific scholarship products such as manuscripts, PowerPoint, etc.
• Assist with basic data analysis
• Engages with community stakeholders and coordinates recruitment activities.
• 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, administering surveys 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.
• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• Proficiency in building, modifying and maintaining REDcap database for the study.
• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• Adheres to cultural competency guidelines; implements strategies to meet study participants' needs for language translation, health literacy, etc.
• Assists in administrative tasks of study personnel including orientation and documenting core competencies.
• 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.

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 for additional information.

Job Status:Full timeEmployee Type:StaffPay Grade:A8

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