Clinical Research Coordinator 2

Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here 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. The University of Miami/UHealth Department of Psychiatry has an exciting opportunity for a full time Clinical Research Coordinator 2 to work in Miami, FL. The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel. Core Responsibilities: Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility. Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols. Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations. Maintains study binders and filings according to protocol requirements, UM and department policy. Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator. Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations. Assists in implementing protocol amendments under direct supervision of the Principal Investigator. Assists with study orientation and protocol related in-services to research team and clinical staff. Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule. Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments. Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews. Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc. 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. Adheres to University and unit-level policies and procedures and safeguards University assets. Department Specific Functions: Plays a key role in supporting the full scope of clinical trial operations. Responsibilities include assisting with participant recruitment, screening, and retention, and ensuring adherence to protocol requirements through study procedures, data collection, specimen handling, and drug accountability. Maintain regulatory binders and documentation, while also monitoring, reporting, and following up on adverse events, protocol deviations, and overall study progress. Facilitate communications with sponsors, monitors, and other institutions. Importantly, this CRC2 role will be dedicated to federally funded studies in areas such as cognitive impairment and schizophrenia, where accurate data collection, strict regulatory compliance, and careful participant oversight are essential to advancing the department’s research mission. 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 required Minimum 2 years of relevant experience required 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. 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 The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation. The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride. The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019. The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022. With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe. The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.