Supervisor, Clinical Research

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 SCCC CRS has an exciting opportunity for a Full-Time Supervisor, Clinical Research to work at UHealth in Miami, Florida.

CORE SUMMARY

The Supervisor, Clinical Research is responsible for independently overseeing the coordination and conduct of complex clinical trials. Acting as a subject matter expert and team leader, this individual plays a key role in clinical study execution, program and operations management, staff development, and regulatory compliance. The position supports cross functional research efforts and ensures adherence to Good Clinical Practice and institutional guidelines.

CORE JOB FUNCTIONS

• Provides guidance, direction, and mentorship to other CRCs. Serving as a resource for the team on compliant conduct of trials.
• Serves as the primary contact for all levels of staff regarding clinical research protocol matters as they relate to the service and protocol databases. This includes a review of standards with staff, identification of deficits, and participating in resolving issues.
• Demonstrates proficiency in utilizing research databases and systems including the Clinical Trial Management System (CTMS), Document Management System (DHS), Microsoft Access, Excel, and Case Report Forms (CRFs) to execute assigned responsibilities and provide support to research personnel.
• Participates or coordinates in both interdepartmental and intradepartmental organization wide research projects as requested. Provides leadership, organizational oversight, and creative input for both established and emerging research projects.
• Works independently or with a team on special projects and initiatives assigned by Manager.
• Attends/leads assigned committees/projects, ensuring that assignments and goals are completed accurately and within the assigned timeframes.
• Provides guidance to research staff on specialized project assignments.
• Provides oversight and direction to research staff in the execution of data management tasks and assigned projects
• Leads project meetings by setting the agenda, following up on action items, and ensures meeting goals are successfully achieved.
• Conducts assessment of key project milestones to determine possible areas for improvement or to evaluate outcomes.
• Leads projects, oversees work of research staff on all research related projects and ensures that assignments and goals are completed accurately and within established timeframes.
• Assists in developing materials and tools necessary to appropriately train individuals involved in conduct of the SDG/CRT trials around issues related to (but not limited to) protocol requirements, scheduled of visits, execution of protocols and maintaining documentation of staff training.
• Participates in the validation process of the study Smartset to ensure accuracy and compliance with the protocols.
• Conducts comprehensive reviews of informed consent documents and eligibility criteria to ensure integrity, completeness, and adherence to SOP 301.
• Conducts team meetings with supervised research staff, and ensures functions are coordinated in a timely and accurate manner according to established guidelines.
• Responsible for support of various research programs and solving any issues as they arise.
• Participates in the recruitment, training and project management of the research staff.
• Works alongside staff to ensure that work is completed on time and monitors the quality of work.
• Provides technical guidance for staff to ensure that issues are resolved and work assignments can be completed within established timeframes; intercedes to resolve problems/issues and reports problems/issues, as appropriate.
• Oversees the development and implementation of an orientation program for new staff.
• Oversee and ensure compliance with regulatory requirements across clinical trials and research operations by monitoring adherence to institutional policies, federal regulations, and sponsor guidelines. Identify and address compliance issues, implement corrective actions as needed, and provide guidance to research staff on regulatory best practices to maintain the integrity of research activities.
• Working knowledge of the Common Rule (45 CFR 46), the Privacy Rule (45 CFR 160, 164) and the regulations that govern human subjects research issued by the Food and Drug Administration (21 CFR 50, 56), and others as needed.
• Understands current standards for Good Clinical Practice (GCP) guidelines defined by the International Committee on Harmonization, FDA, NCI/NIH, OHRP, and the Office of Civil Rights, and according to state and institutional regulations.
• Oversee internal audits to ensure that the data collected is complete and accurate and to ensure that the study was carried out as outlined to ensure that data collected has no typographical errors, is consistent with source documents, and follows external sponsor/regulatory requirements.
• Ensures data quality and integrity in research and/or service/departmental databases for each stage of data collection. Ensure all source documentation that supports data collected is available for review.
• Collaborate in the preparation of internal and external audits of a protocol (e.g. conducts pre-audit chart review, ensures regulatory binder is complete) and may independently represent the SDG/CRT team upon site visits by sponsors representatives.
• With guidance from the Manager, creates and ensures distribution and implementation of Corrective Action Plans (CAPA).
• Assists the Manager with departmental audit reports, generating the final audit report and, if required, corrective action.elop, and train others.

CORE QUALIFICATIONS

Education: Bachelor’s degree in relevant field required

Experience: Minimum 5 years of relevant experience required

Knowledge, Skills and Abilities:

- Performance Management: Ability to set performance goals, provide feedback, conduct evaluations, and

effectively delegate tasks.

- Training & Development: Providing employee training and motivation to enhance skills.

- Team Leadership: Ability to create and maintain a cohesive and productive team environment, build positive

working relationships and work collaboratively with others.

- Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.

- Communication: Strong verbal and written communication skills to convey ideas clearly and persuasively

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:

Employee Type:

About Us

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.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.