Job Information
University of Miami Clinical Research Coordinator 3 in Miami, Florida
Current Employees:
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The Department of Otolaryngology is currently seeking a full time Clinical Research Coordinator 3 to work in Miami, FL. The Clinical Research Coordinator 3 serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies’ daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study’s integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.
CORE JOB FUNCTIONS
- Coordinates the implementation of multiple complex clinical research protocols.2. Develops SOPs and templates with guidance from the PI/Clinical Research Manager.3. Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.4. Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.5. Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions.6. Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.7. Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.8. Provides leadership in identifying and working through ethical conflicts arising during protocol implementation and refers these conflicts to the Research Ethics Team for consults as needed.9. Organizes/manages site visits and internal/external auditing activities as assigned.10. Coordinates research team meetings; assures communications across-the-board.11. Assures synchronization of study visits/procedures/ clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.12. Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.13. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.14. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.15. 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
Education:
Bachelor’s degree in relevant field
Certification and Licensing:
Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months
Experience:
Minimum 4 years of relevant experience
DEPARTMENT ADDENDUM
Department Specific Functions
Purpose:
Clinical and outcomes research, coordination with translational and social science research; management of complex research data collection infrastructure; coordination and organization for clinical research involving patients with chronic and serious illness.
Position dimensions include:
Interfacing across departments; working with research subjects; data infrastructure management; helping with the development of research publications; contributing to grant applications; involvement with sponsored studies, training and supervision of research assistants and trainees.
Working Environmental Conditions:
Working on a collaborative research team with the PI, research assistants, and collaborators; liaison with informational technology and electronic medical record personnel; direct subject contact for consents and longitudinal follow-up, focus groups; videoconferencing meetings and in-person meetings.
The majority of work will be on the main UM medical campus with occasional travel to satellite clinics. May require intermittent evening or after hours commitments.
Department Specific Qualifications
Education:
Minimum education: experience in Medicine, Health Services, Public Health, or related fields. Graduate education encouraged.
Advanced Spanish Language and English fluency required.
Certification and Licensing:
Must have or obtain compliance with all Research certifications, including Good Clinical Practice and Blood borne pathogens.
Appropriate certifications and training in consenting patients, clinical research ethics, and regulatory research management
Experience:
3 or more years of minimum work experience in: Direct patient research, including consenting, quantitative methodological skills, database management, and experience with clinical research regulatory compliance.
Capacity to independently run day-to-day operations for complex research studies. Experience working with patients.
Knowledge, Skills and Attitudes:
Contributes to clinical and applied research activities including data collection, consenting patients, longitudinal patient follow-up, subject tracking, maintaining regulatory compliance, IRB submissions and modifications, and authors technical and agency reports.
Collaborates with the PI and senior staff on the development of research publications.
Creates and conducts clinical research and basic descriptive analysis of the results.
Manages clinical databases
Run day-to-day operations for large complex research studies, including PI-driven research, grant-funded research, and sponsored studies
Assists the PI and senior staff in preparing materials for submission to granting agencies and foundations.
Provides ready access to all experimental data for senior staff and research team
Requests or acquires equipment and supplies for assigned project(s).
Uses the Internet, surveys, databases, electronic medical record, and other available sources to collect research information.
Interfaces across departments with research collaborators, and funding agencies.
Participation in new skill development
Assist with qualitative research
Skill in collecting, organizing and analyzing data.
Ability to recognize, analyze, and solve a variety of problems.
Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
Ability to process and handle confidential information with discretion.
Ability to work independently and/or in a collaborative environment.
#ED-LI1
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 (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
A10
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.
Transforming lives
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.
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