Lead Clinical Research Coordinator
Company: Renown Health
Posted on: August 24, 2019
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
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:
- 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
a. Clinical research protocol identification and appropriateness
for Renown Health.
b. Assists, as needed, with IRB submission and protocol start up
- 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
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.
- 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
b. Makes quality improvement recommendations as necessary.
- The incumbent educates and mentors new clinical research
- 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
- The incumbent must master the knowledge and skills necessary to
provide evidence based care appropriate to the study
- 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..
- 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.
Requirements - Required and/or Preferred
Possess Bachelors Degree in health science or related field and
must possess 2 years of experience in clinical trials. Must have
working-level knowledge of the English language, including reading,
writing and speaking English.
Two-years of experience as Clinical Research Coordinator or
Previous experience caring for patients on a research protocol.
Demonstrated experience in prioritizing and organizing work
Valid State of Nevada or California driver's license and ability to
pass Renown Health's Department of Motor Vehicle Report
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.
Keywords: Renown Health, Reno , Lead Clinical Research Coordinator, Healthcare , Reno, Nevada
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