The Lead Clinical Research Coordinator has expert experience in the discipline of research assignment and provides leadership over the coordinator pool in the Office of Research and Education (ORE). The incumbent is responsible, in collaboration with the Study Coordinators and the Study Principle Investigators (PIS), for study oversight, coordination and management of the clinical trials program as it pertains to research. This includes the regulatory activities, coordination of care for the research subjects, consent, screening and enrollment in clinical studies, drug accountability, management (including financial monitoring, research calendars, documentation, data collection and reporting) of the subjects’ activities throughout the term of the identified research studies up to and including study close-out. Additionally, the position requires preceptorship and mentoring of clinical research coordinators and is a resource for all department research staff.
Nature and Scope:
The incumbent is challenged to oversee the clinical research coordinator pool and research protocols with an extremely high degree of accuracy. While the incumbent must be highly organized and tolerant of isolation, this person must also have good interpersonal skills to communicate with research staff, with physicians and with physician staff. This position prepares, submits and monitors documentation of research program activities while assuring compliance with regulations and protocols. Performs assigned clerical and technical duties as directed. Back office duties, data entry, scheduling subjects, consenting subject, coordinator pool training, staff evaluations and staff career development. Completes other work as required.
Serves as a Renown Health Lead Clinical Research Coordinator in the Office of Research and Education:
1. The incumbent oversees in close collaboration with study coordinators, study PIs and other providers to actively identify the feasibility of new clinical trials, to responsibly negotiate study contracts and to develop liaisons with collaborators, sponsors, and external regulatory agencies to facilitate this process.
a. Clinical research protocol identification and appropriateness for Renown Health.
b. Assists, as needed, with IRB submission and protocol start up processes.
2. The incumbent oversees and manages study subjects’ care activities, as assigned, including, but not limited to
a. Patient screening and enrollment.
b. Responsible for management of enrolled patient (subject) including calendar management, data collection and submission, clinical coordination and documentation, timely reporting of adverse events and off-study process.
c. Responsible for protocol management for the term of the open clinical protocol, including facilitation of study closer as appropriate.
d. Responsible for the coordination of research projects including the coordination with physicians, pathology staff, imaging staff, technicians, research staff, caring for the patient types enrolled in a research study.
3. Assists in the oversight of research trials compliance.
a. Monthly audits, as assigned, on active clinical research trials for protocols, regulatory and billing compliance and reports findings to PIs, ORE directors, department manager and appropriate research staff.
b. Makes quality improvement recommendations as necessary.
4. The incumbent educates and mentors new clinical research staff.
5. Knowledge and application of regulatory requirements pertinent to clinical trial conduct are required [including Federal Guidelines on Human Subjects in Research, International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Joint Commission (JC), International Air Transport Association (IATA) and other regulatory agencies as appropriate].
6. The incumbent must master the knowledge and skills necessary to provide evidence based care appropriate to the study discipline.
7. Mastery of clinical trials practice; along with critical thinking skills are required to provide optimally safe practice when interacting with internal and external contacts and exercising judgment and making decisions..
8. It is common to encounter potential hazards in the healthcare environment. Some of these hazards could include, but are not limited to: radiation, toxic chemicals, biological hazards, heat, noise, dust and stress. Renown Health has a Safety Management Program in place that addresses these issues.
This position is challenged to manage a large volume of items while maintaining a high degree of accuracy and efficiency with significant attention to detail. Working knowledge of all regulatory requirements governing IRB guidelines. The position requires strong decision-making, independent judgment and analytical skills in order to apply federal and state regulations to a variety of situations.
This position may provide patient care.
The foregoing description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills and efforts or work conditions associated with the job. It is intended to be an accurate reflection of the general nature and level of the job.
Minimum Qualifications: Requirements – Required and/or Preferred
* Possess Master’s degree in health science, or must possess 5 years of experience in clinical trials and be in pursuit of Master’s degree, obtained within 24 months of hire.
* Must have working-level knowledge of the English language, including reading, writing and speaking English.
* Two-years of experience as Clinical Research Coordinator or equivalent
* Previous experience caring for patients on a research protocol.
* Demonstrated experience in prioritizing and organizing work preferred.
* Valid State of Nevada or California driver’s license and ability to pass Renown Health’s Department of Motor Vehicle Report criteria.
* Valid Clinical Research Certification, SoCRA or ACRP Certification required to be obtained within 24 months of hire
Computer / Typing:
* Must be proficient with Microsoft Office Suite, including Outlook, PowerPoint, Excel and Word and have the ability to use the computer to complete online learning requirements for job-specific competencies, access online forms and policies, complete online benefits enrollment, etc.