Supervisor, Clinical Research

University of Miami•Miami, FL

8d•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 contributes to 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. The supervisor leads and supports research staff, coordinates projects and meetings, monitors milestones and work quality, and helps resolve operational issues. The role also oversees data management and quality, study documentation, training, and regulatory compliance across clinical trials and research operations. The position may represent the SDG/CRT team during sponsor site visits and assists with internal and external audits and corrective action plans.

Requirements

Bachelor’s degree in a relevant field.
At least 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), FDA human-subjects research regulations (21 CFR 50, 56), and other applicable regulations.
Knowledge of current Good Clinical Practice guidelines and relevant FDA, NCI/NIH, OHRP, Office for Civil Rights, state, and institutional standards.

Responsibilities

Provide guidance, direction, and mentorship to Clinical Research Coordinators and other research staff on compliant trial conduct and specialized assignments.
Serve as a primary resource for staff on clinical research protocol matters, review standards, identify deficits, and participate in resolving issues.
Use research databases and systems, including CTMS, DHS, Microsoft Access, Excel, and Case Report Forms, to perform responsibilities and support research personnel.
Participate in or coordinate interdepartmental and intradepartmental research projects, providing leadership, organizational oversight, and creative input.
Work independently or with a team on special projects and initiatives assigned by the Manager.
Attend or lead committees and projects, ensuring assignments and goals are completed accurately and on time.
Oversee research staff in data management tasks and assigned projects.
Lead project meetings, set agendas, follow up on action items, and ensure meeting goals are achieved.
Assess project milestones to identify opportunities for improvement or evaluate outcomes.
Lead research projects and oversee staff work to ensure assignments and goals are completed accurately and within established timeframes.
Help develop training materials and tools for individuals involved in SDG/CRT trials, including materials on protocol requirements, visit schedules, protocol execution, and staff training documentation.
Participate in validating study Smartsets for accuracy and protocol compliance.
Review informed consent documents and eligibility criteria for integrity, completeness, and compliance with SOP 301.
Conduct meetings with supervised staff and coordinate functions according to established guidelines and timeframes.
Support research programs and resolve issues as they arise.
Participate in recruitment, training, and project management of research staff; 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 an orientation program for new staff.
Monitor compliance with institutional policies, federal regulations, and sponsor guidelines; identify compliance issues, implement corrective actions as needed, and advise staff on regulatory best practices.
Apply working knowledge of the Common Rule, Privacy Rule, FDA human-subjects regulations, and other applicable regulations.
Apply current Good Clinical Practice standards and relevant FDA, NCI/NIH, OHRP, Office for Civil Rights, state, and institutional requirements.
Oversee internal audits to verify data completeness and accuracy and confirm that studies were conducted as outlined and meet sponsor and regulatory requirements.
Ensure data quality and integrity in research and departmental databases and confirm supporting source documentation is available for review.
Collaborate on internal and external protocol audits, including pre-audit chart reviews and regulatory binder checks, and independently represent the SDG/CRT team at sponsor site visits when needed.
With Manager guidance, create and ensure distribution and implementation of Corrective Action Plans.
Assist the Manager with departmental audit reports, including preparation of final reports and corrective actions when required.