Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here (https://www.myworkday.com/umiami/d/task/1422$7248.htmld) to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 1 to work at the UHealth campus in Miami, Fl. CORE JOB SUMMARYThe Clinical Research Coordinator 1 serves as an entry-level clinical research professional that has a foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. The incumbent is responsible for simple clinical research protocols and timelines.CORE JOB FUNCTIONS1. Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.2. Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.3. Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.4. Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.5. Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.6. Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.7. Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.8. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.9. Knows the contents and maintenance of study-specific clinical research regulatory binders.10. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.11. Adheres to University and unit-level policies and procedures and safeguards University assets. 12. 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 QUALIFICATIONSEducation: Bachelor’s degree in relevant field requiredExperience: Minimum 1 year of relevant experience requiredKnowledge, Skills and Abilities: + Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands. + Teamwork: Ability to work collaboratively with others and contribute to a team environment. + Technical Proficiency: Skilled in using office software, technology, and relevant computer applications. + Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders. Department Specific Functions + 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 in order to correct data issues in a timely manner. + Ensures that protocol lab kits and study specific supplies are obtained/ordered as necessary. + 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. + Performs patient phlebotomy by prescribed technique outlined in the phlebotomy procedure manual. + Maintain patient charts in accordance to institutional and federal guidelines. + Facilitates shipping/processing of biospecimen samples as dictated per protocol(s). + Performs other related duties as assigned. 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. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Job Status: Full time Employee Type: Staff