Clinical Research Associate 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 AND 4 years of clinical research monitoring experience, AND a total of 6 years of research experience in a healthcare setting; OR
Associates degree in life sciences subject, including Medical Research, Nursing or related healthcare field AND 4 years of clinical research monitoring experience, AND a total of 8 years of research experience 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.
10 years total of research experience in a healthcare setting.
Oncology experience and/or Phase 1 research is desirable.
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.