Manager, Quality Assurance

University of Miami•Miami, FL

6d•Remote

About The Position

The Manager, Quality Assurance conducts routine, focused, and directed audits of human subject research protocols to ensure compliance with federal and local regulations and guidelines, and research site specific standard operating procedures. The incumbent on this position advises appropriate institutional officials of deficiencies, and recommends necessary corrective actions, with follow up to ensure that needed actions have been implemented. The Manager, Quality Assurance also trains and mentors quality assurance auditors. The position develops, verifies, and implements procedures to accomplish SCCC research quality improvement goals. Reviews research protocol compliance and participant adherence to protocol: Reviews documentation of patient/participant screening procedures completed by Principal Investigator and CRS staff and reviews relevant medical information from patient clinic charts/medical records. Reviews logs/progress reports to track protocol compliance for both currently enrolled as well as follow-up patients/participants. Determines data to be collected and provides QC of Clinical Trial Management System (CTMS): Develops forms for collecting/summarizing data. Ensures data integrity and consistency in CTMS and written records. Supports corrections/queries resolution of audits/monitor visits and takes action to develop and implement CAPAs as needed. Establishes/maintains contact with CRS employees, health care providers, community agencies and study sponsors. Updates appropriate agencies (such as sponsors, IRB, etc.) regarding status of research projects. Provides education to staff about research protocols. Supports the development and implementation of a CRS employee orientation program. Participates in the implementation coordination and execution of the continuing education program for CRS employees. Assists with the design, conduct, and implementation of education and training programs for investigators, clinical research coordinators, and research staff in general and with specific emphasis on cooperative group trials. Works closely with the CRS, Director Quality Assurance Unit. other CRS staff, and outside quality control/quality assurance personnel, on overseeing all CAPA initiatives. Provides support for, and coordination of quality initiatives primarily for the National Group protocols and non-IND Investigator Initiated Studies. This includes working with CRS staff to address data timeliness and query resolution. Supports the development and management of the CRS SOP portfolio. Participates in the development of general goals, process improvement plans, and training activities related to research compliance. Works closely with the CRS Director, Quality Assurance Unit to develop and enhance systems and processes as required to improve efficiencies, compliance, and quality of the CRS operation.

Requirements

Bachelor’s Degree in relevant field
Minimum 5 years relevant experience
Ability to maintain effective interpersonal relationships
Ability to communicate effectively in both oral and written form
Skill in collecting, organizing, and analyzing data
Ability to recognize, analyze, and solve a variety of problems
Ability to exercise sound judgment in making critical decisions
Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates or obtained within 1 year of hire.
Medical and/or science education strongly preferred.
Oncology and cooperative group clinical trial experience preferred.
High-level interpersonal skills are required.
Excellent English oral and written communication skills required.
Thorough understanding of Good Clinical Practice guidelines and the Code of Federal Regulations required.
Proficient with Microsoft Office Suite including Excel and Power Point.
Knowledge of medical terminology.
Ability to manage multiple tasks simultaneously.
Attention to detail & accuracy.

Responsibilities

Remains in compliance with federal, state, and local regulations, and extramural agencies' requirements, and conducts inquiries of laboratories and research protocols.
Prepares reports of investigations and inquiries for internal or external use.
Assists in the preparation and presentation of educational programs.
Conducts the preparation of research teams for FDA or other regulatory agency audits.
Assists research teams with required written responses to observations resulting from audits conducted by regulatory agencies.
Reviews audit reports and plans of quality assurance auditors.
Monitors new legislation or changes in regulations that might affect the University's compliance in conducting research and recommends changes to administrative policies and procedures.
Creates, revises, and maintains internal policies and standard operating procedures, as well as University-wide policies intended to assist University researchers in maintaining compliance with research standards and guidelines.
Assists with the preparation of annual reports, summarizing efforts taken and changes to be implemented at both University and department levels.
Maintains quality assurance related databases and electronic and paper audit files.
Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures.
Ensures employees are trained on controls within the function and on University policy and procedures.
Develops, verifies, and implements procedures to accomplish SCCC research quality improvement goals.
Reviews research protocol compliance and participant adherence to protocol.
Reviews documentation of patient/participant screening procedures completed by Principal Investigator and CRS staff and reviews relevant medical information from patient clinic charts/medical records.
Reviews logs/progress reports to track protocol compliance for both currently enrolled as well as follow-up patients/participants.
Determines data to be collected and provides QC of Clinical Trial Management System (CTMS).
Develops forms for collecting/summarizing data.
Ensures data integrity and consistency in CTMS and written records.
Supports corrections/queries resolution of audits/monitor visits and takes action to develop and implement CAPAs as needed.
Establishes/maintains contact with CRS employees, health care providers, community agencies and study sponsors.
Updates appropriate agencies (such as sponsors, IRB, etc.) regarding status of research projects.
Provides education to staff about research protocols.
Supports the development and implementation of a CRS employee orientation program.
Participates in the implementation coordination and execution of the continuing education program for CRS employees.
Assists with the design, conduct, and implementation of education and training programs for investigators, clinical research coordinators, and research staff in general and with specific emphasis on cooperative group trials.
Works closely with the CRS, Director Quality Assurance Unit. other CRS staff, and outside quality control/quality assurance personnel, on overseeing all CAPA initiatives.
Provides support for, and coordination of quality initiatives primarily for the National Group protocols and non-IND Investigator Initiated Studies.
Works with CRS staff to address data timeliness and query resolution.
Supports the development and management of the CRS SOP portfolio.
Participates in the development of general goals, process improvement plans, and training activities related to research compliance.
Works closely with the CRS Director, Quality Assurance Unit to develop and enhance systems and processes as required to improve efficiencies, compliance, and quality of the CRS operation.