Supervisor, Clinical Research

University of Miami•Miami, FL

7d•Onsite

About The Position

The Supervisor, Clinical Research independently oversees the coordination and conduct of complex clinical trials. As a subject matter expert and team leader, the role supports clinical study execution, research program and operations management, staff development, and regulatory compliance. The Supervisor supports cross-functional research efforts and ensures adherence to Good Clinical Practice and institutional guidelines. The position provides leadership and operational oversight for research projects and programs, supervises and develops research staff, and supports clinical research data management. It oversees regulatory compliance, data quality, documentation, and audit preparation across clinical trials and research operations. The Supervisor collaborates with the Manager, staff, and other departments to resolve issues, improve processes, and complete projects accurately and on time.

Requirements

Bachelor’s degree in a relevant field.
Minimum of 5 years of relevant experience.
Ability to set performance goals, provide feedback, conduct evaluations, and delegate tasks effectively.
Ability to provide employee training and motivation to enhance skills.
Ability to build and maintain a cohesive, productive team environment and positive working relationships, and to collaborate with others.
Proficiency with office software, technology, and relevant computer applications.
Strong verbal and written communication skills.
Working knowledge of the Common Rule (45 CFR 46), the Privacy Rule (45 CFR 160, 164), and FDA regulations governing human-subject research (21 CFR 50, 56), as well as other applicable regulations.
Understanding of current Good Clinical Practice guidelines and standards defined by ICH, FDA, NCI/NIH, OHRP, and the Office for Civil Rights, and applicable state and institutional regulations.

Responsibilities

Provide guidance, direction, and mentorship to clinical research coordinators and other research staff, serving as a resource on compliant trial conduct.
Serve as the primary contact for staff regarding clinical research protocol matters related to service and protocol databases; review standards, identify deficits, and participate in resolving issues.
Use research databases and systems, including CTMS, DHS, Microsoft Access, Excel, and CRFs, to perform assigned responsibilities and support research personnel.
Participate in or coordinate interdepartmental and intradepartmental research projects and provide leadership, organizational oversight, and creative input for established and emerging projects.
Work independently or with a team on special projects and initiatives assigned by the Manager.
Attend or lead assigned committees and projects, and ensure assignments and goals are completed accurately and within timeframes.
Guide research staff on specialized project assignments and oversee data management tasks and assigned projects.
Lead project meetings by setting agendas, following up on action items, and ensuring meeting goals are achieved.
Assess key project milestones to identify improvement opportunities or evaluate outcomes.
Lead projects and oversee research staff work to ensure assignments and goals are completed accurately and on time.
Assist in developing materials and tools to train individuals involved in SDG/CRT trials on protocol requirements, visit schedules, protocol execution, and documentation of staff training.
Participate in validating study Smartsets for accuracy and protocol compliance.
Review informed consent documents and eligibility criteria for integrity, completeness, and adherence to SOP 301.
Conduct team meetings with supervised staff and ensure work is coordinated promptly and accurately according to established guidelines.
Support research programs and resolve issues as they arise.
Participate in recruiting, training, and project management of research staff; work alongside staff to monitor timeliness and quality of work.
Provide technical guidance, resolve or escalate problems, and help staff complete assignments within established timeframes.
Oversee development and implementation of orientation for new staff.
Monitor clinical trials and research operations for compliance with institutional policies, federal regulations, and sponsor guidelines; identify compliance issues, implement corrective actions, and advise staff on regulatory best practices.
Apply working knowledge of the Common Rule, Privacy Rule, FDA human-subject research regulations, and applicable Good Clinical Practice guidelines and regulations.
Oversee internal audits to verify data completeness and accuracy, compliance with study procedures, consistency with source documents, and adherence to sponsor and regulatory requirements.
Ensure data quality and integrity throughout each stage of data collection and ensure supporting source documentation is available for review.
Collaborate in preparing internal and external protocol audits, including pre-audit chart reviews and regulatory binder completion; represent the SDG/CRT team during sponsor site visits when needed.
With guidance from the Manager, create and ensure distribution and implementation of Corrective Action Plans (CAPA).
Assist the Manager with departmental audit reports, including preparation of final audit reports and corrective actions when required.