Supervisor, Clinical Research

University of Miami Miller School of Medicine•Miami, FL

59d

About The Position

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.

Requirements

Bachelor's degree in a relevant field
Three years of relevant experience
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.

Responsibilities

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.