Clinical Research Monitor III â“ Research Administration - Orlando
Location Address: 601 E. Rollins St., Orlando, FL 32801
Top Reasons to work at AdventHealth Orlando
Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando
serves as the major tertiary facility for much of the Southeast, the Caribbean and South America
AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country
We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year
Full Time, Days
You Will Be Responsible For:
The Clinical Research Monitor III is a research professional, who possesses knowledge and understanding of complex regulatory requirements related to human subject research and execution of clinical trials to conduct clinical research monitoring visits in support of our investigator initiated clinical trials. The Clinical Research Monitor conducts and/or participates in 1) Site Initiation Visits, 2) Interim Monitoring Visits, and 3) Study Closeout Visits with the purpose of promoting safety of the study participants, research compliance, data integrity, and overall study quality. Primary efforts and responsibilities are centered on Sponsor-Investigator initiated studies (IIS). The clinical research monitors priorities include studies conducted in the AHRI phase 1 Clinical Research Unit (CRU) and all IIS conducted in support of National Cancer Institute (NCI) application/designation and maintenance thereafter. The Clinical Research Monitor III will assist in orienting new clinical research monitors, participate in the Research Training & Education Program, and serve as lead in preparing departments for external audits
What You Will Need:
Bachelorâ™s degree (BA/BS) in life sciences subject, including Medical Research, Nursing or related healthcare field
A minimum of 2 years of experience as a Clinical Research Monitor in a clinical setting.
5 years of experience in relevant therapeutic or clinical area in a healthcare setting.
Research certification, or other related certification from a professional research association such as: Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates (SOCRA), Certified Clinical Research Coordinator (CCRC) from the Association of Clinical Research Professionals (ACRP), OR Certified Clinical Research Associate (CCRA) from the Association of Clinical Research Professionals (ACRP)
Application of complex regulations and guidelines, such as CFR, ICH, state law and SOPs applicable to human subject protection and clinical research.
Knowledge and understanding of complex research regulations including, Office of Human Research Protection (OHRP), International Conference on Harmonization (ICH), Food and Drug Administration (FDA) regulations, FDA IND/IDE/Biologics Applications, Office of Inspector General (OIG), HIPAA Privacy Rules and Regulations as they relate to research, AHRI Institutional Review Board (IRB), Central IRBs, and AHRI research services review and approval processes.
Critical thinking and analytical skills necessary for problem-solving and conducting or directing thorough, accurate, and effective monitoring activities
Proficient in MS Office Suite, and internet skills.
Working knowledge of various Electronic Data Capture and Clinical Trial Monitoring systems
Current active State of Florida Registered Nurse or other professional licensure consistent with health-related healthcare degree as applicable
Masterâ™s degree in life sciences subject, including medical research, Nursing, or related healthcare field.
5 years of research experience as a Clinical Research Monitor, oncology experience and/or phase 1 research is desirable.
AdventHealth Institutional Review Board (IRB) requirements and processes, review and approval processes.
Wide ranging healthcare knowledge
Experience with Clinical Conductor and/or OpenClinica systems
In coordination with the Research Compliance Manager, orients, trains, provides guidance to new clinical research monitors as well as to achieve departmental goals and objectives.
Conducts objective and independent onsite clinical research monitoring visits of selected research programs/studies reviewing regulatory documents, research records, and the source data for data elements recorded for the purpose of protocol adherence, source data verification for data integrity, compliance with GCP guidelines, applicable Federal regulations, and AHRI policies and procedures, as well as any external IRB requirements.
Evaluates documentation for demonstration of adequate Principal Investigator (PI) oversight of the study and study participants.
Provides guidance to the research departments, study teams, research investigators and staff to promote compliance with the research-related Code of Federal Regulations, International Conference of Harmonization (ICH) Good Clinical Practice (GCP) standards, AHRI policies and procedures, and all other applicable requirements, standards and guidelines. This requires interaction with all levels of management and staff.
Independently develops monitoring plans specific to individual study protocols with guidance and/or input from Research Compliance Manager.
Monitors assigned research studies in accordance with study specific clinical data Monitoring Plan.
Generates queries and conducts follow-up of queries and non-compliance issues ensuring resolution in a timely manner.
Documents findings in a monitoring report for all visits conducted in a timely manner and according to the Monitoring Plan for that study.
Provides direction to study team when events and other reportable information must be submitted to the IRB of record for that study and any other required parties.
Report deficiencies and develop Corrective and Preventative Action (CAPA) plans with guidance and/or input from the Research Compliance Manager.
Follow-up on all CAPAs for resolution within the designated follow up timeframe prescribed, ensuring all required actions have been completed.
Maintain monitoring activities and aggregate results (reports, responses, queries, non-compliance, follow-up activities, etc.) in a database for the purposes of generating monitoring summary reports, and to track areas of non-compliance identified, internal metrics, etc. These reports and findings may be communicated to the Research Oversight Committee, Research Education & Communications Program Manager, and AHRI leadership, investigators, and staff.
Lead team in preparing departments for external audits. This will include educating the team on what to expect, reviewing records, and assisting team in audit prep activities. This will require direct interaction with external auditors including federal government officials such as FDA and OHRP.
Provides instructions and serves as subject matter expert to Clinical Research Coordinators (CRC), Regulatory staff, Investigators, and other research team members regarding AHRI policies and standard operating procedures, and Good Clinical Practice guidelines. Provides support and direction to the research team during clinical research monitoring visits.
Participates in the Research Education/Training program as a speaker on research-related topics to AHRI research investigators and staff.
AdventHealth Greater Orlando (formerly Florida Hospital) is one of the largest faith-based health care providers in the United States. For 150 years, we have carried on a tradition of providing whole-person care that not only addresses patients' physical ailments, but also supports their emotional and spiritual well-being. We demonstrate the same level of compassion and care for our employees as well, doing all that we can to help them realize their full potential – both personally and professionally.