University of Miami
Supervisor, Clinical Research – University of Miami
Join to apply for the
Supervisor, Clinical Research
role at the
University of Miami . The
University of Miami/UHealth Department of SCCC - CRS
has an exciting opportunity for a Full Time Supervisor, Clinical Research to work at the UHealth campus in Miami, Fl.
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 and serves 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.
Demonstrates proficiency in utilizing research databases and systems including the CTMS, DHS, Microsoft Access, Excel, and CRFs.
Participates or coordinates in interdepartmental and intradepartmental organization‑wide research projects to provide leadership, oversight, and creative input.
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 ensuring meeting goals are successfully achieved.
Conducts assessment of key project milestones to determine possible areas for improvement or to evaluate outcomes.
Assists in developing materials and tools necessary to appropriately train individuals involved in the conduct of the SDG/CRT trials.
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 to ensure 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.
Oversees the development and implementation of an orientation program for new staff.
Ensures compliance with regulatory requirements across clinical trials and research operations by monitoring adherence to institutional policies, federal regulations, and sponsor guidelines.
Has working knowledge of the Common Rule, the Privacy Rule, and FDA regulations governing human subjects research.
Understands current standards for Good Clinical Practice guidelines.
Oversees internal audits to ensure that the data collected is complete and accurate and that the study was carried out as outlined.
Ensures data quality and integrity in research and/or service/departmental databases for each stage of data collection.
Collaborates in the preparation of internal and external audits of a protocol.
With guidance from the Manager, creates and ensures distribution and implementation of Corrective Action Plans.
Assists the Manager with departmental audit reports, generating the final audit report and corrective action as needed.
Core Qualifications Education:
Bachelor’s Degree in a relevant field.
Experience:
Minimum 3 years of relevant experience.
Knowledge, Skills and Attitudes
Knowledge of business and management principles.
Ability to direct, manage, implement, and evaluate department operations.
Ability to establish department goals and objectives that support the strategic plan.
Ability to effectively plan, delegate and/or supervise the work of others.
Compensation and Benefits The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission, and more.
Job Status Full time
Employee Type Staff
Pay Grade A12
Equal Opportunity Employer 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.
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Supervisor, Clinical Research
role at the
University of Miami . The
University of Miami/UHealth Department of SCCC - CRS
has an exciting opportunity for a Full Time Supervisor, Clinical Research to work at the UHealth campus in Miami, Fl.
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 and serves 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.
Demonstrates proficiency in utilizing research databases and systems including the CTMS, DHS, Microsoft Access, Excel, and CRFs.
Participates or coordinates in interdepartmental and intradepartmental organization‑wide research projects to provide leadership, oversight, and creative input.
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 ensuring meeting goals are successfully achieved.
Conducts assessment of key project milestones to determine possible areas for improvement or to evaluate outcomes.
Assists in developing materials and tools necessary to appropriately train individuals involved in the conduct of the SDG/CRT trials.
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 to ensure 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.
Oversees the development and implementation of an orientation program for new staff.
Ensures compliance with regulatory requirements across clinical trials and research operations by monitoring adherence to institutional policies, federal regulations, and sponsor guidelines.
Has working knowledge of the Common Rule, the Privacy Rule, and FDA regulations governing human subjects research.
Understands current standards for Good Clinical Practice guidelines.
Oversees internal audits to ensure that the data collected is complete and accurate and that the study was carried out as outlined.
Ensures data quality and integrity in research and/or service/departmental databases for each stage of data collection.
Collaborates in the preparation of internal and external audits of a protocol.
With guidance from the Manager, creates and ensures distribution and implementation of Corrective Action Plans.
Assists the Manager with departmental audit reports, generating the final audit report and corrective action as needed.
Core Qualifications Education:
Bachelor’s Degree in a relevant field.
Experience:
Minimum 3 years of relevant experience.
Knowledge, Skills and Attitudes
Knowledge of business and management principles.
Ability to direct, manage, implement, and evaluate department operations.
Ability to establish department goals and objectives that support the strategic plan.
Ability to effectively plan, delegate and/or supervise the work of others.
Compensation and Benefits The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission, and more.
Job Status Full time
Employee Type Staff
Pay Grade A12
Equal Opportunity Employer 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.
#J-18808-Ljbffr