Coordinates the planning, implementation, and monitoring of clinical research studies within the Department of Pathology. Manages day-to-day operations including participant recruitment, specimen processing, and maintenance of study databases.
Requirements summary
Requires a bachelor's degree in a relevant field and at least 2 years of experience in clinical and translational research. Must have familiarity with biospecimen management and proficiency with research informatics tools like REDCap and CoPath.
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 Department of Pathology has an exciting opportunity for a full-time Clinical Research Coordinator 2, to work on-site in Miami. CORE JOB SUMMARY 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. The Department of Pathology and Laboratory Medicine (DPLM) is a growing multi-disciplinary department at the University of Miami Miller School of Medicine.
It encompasses 4 distinct divisions: Anatomic Pathology, Hematopathology, Comparative Pathology, and Laboratory Medicine. DPLM Research includes all divisions and is divided according to basic, translational, and clinical research. The position of Clinical Research Coordinator 2 at DPLM is expected to conduct and support pathology research projects. CORE JOB FUNCTIONS 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 JOB FUNCTIONS Plan, implement, and monitor pathology clinical research study requests requesting pathology specific services. Participate in the development and revision of internal Standard Operating Procedures (SOP) in the delivery of pathology services Conduct all pathology research related requests, which includes searches using coPath, and managing faculty research databases using several software such as Qualtrics, Sharepoint, and REDCap. Keep faculty individual databases to capture all consult cases databases. Participate and coordinate new pathology research projects. Assist faculty with iLab requests for the Translational Research Histology Laboratory. Coordinate proper retrieval of pathology materials and ensure proper review, delivery, and return of requested samples (slides and blocks). Monitor internal pilot award projects and acts a liaison with the DPLM faculty. Prepare powerpoint presentation and other visual material related to all research processes for DPLM faculty. Participate in all research DPLM activities and conferences, including the DPLM Research Day. Learn and implement AI-driven projects to assist in improving research and/or research workflows 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 Experience supporting clinical and translational research within a pathology or laboratory medicine environment Familiarity with biospecimen management, including retrieval, processing, tracking, and storage of tissue samples (e.g., slides, FFPE blocks, fresh specimens) Experience coordinating pathology-related study requests and services, including collaboration with investigators and core laboratories Knowledge of anatomic pathology and/or laboratory medicine workflows and their integration into clinical research studies Experience working with research databases and informatics tools (e.g., REDCap, CoPath, SharePoint, Qualtrics) for specimen tracking and study management Understanding of regulatory and compliance requirements related to human subject research, biospecimens, and HIPAA
Benefits
Medical
Dental
Tuition Remission
Knowledge, 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. Knowledge of biospecimen lifecycle management (collection → processing → storage → distribution) Familiarity with histology, molecular pathology, or laboratory-based assays Ability to manage data integrity and specimen linkage across clinical and research systems This is a core job profile description and is not reflective of all duties that may be assigned to a specific position in each individual department. The above statements are intended to describe the general nature and primary responsibilities of this core job profile. Specific duties and tasks may vary based upon departmental needs. Other duties may be assigned to the above consistent with the knowledge, skills, and abilities required for the job. 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.
