Clinical Research Coordinator
Company: Odyssey Systems Consulting Group, Ltd.
Location: Las Vegas
Posted on: May 4, 2021
Odyssey Systems has an exciting new opportunity for a Clinical
Research Coordinator supporting the Clinical Investigation Program
at the 99th Medical Group at Nellis AFB, Nevada.
The primary mission of the regional CIP at the 99th Medical Group
(MDG) is to support Graduate Medical Education research at the 99
MDG, 96th MDG, 375 MDG and any other collaborating research
locations including the VA Southern Nevada Healthcare System. In
conjunction with the Nellis Family Medicine Residency, CIP
researchers constantly pursue the advancement of military
healthcare, utilizing cutting-edge strategies and methods. As part
of the Regional CIP, Nellis CIP researchers also assist Eglin,
Scott and any other bases participating under the Regional CIP
program with many of the regulatory duties and processes related to
their research programs, including assistance with
renewing/updating their DoD Assurance, Institutional Review Board
(IRB) submissions and guidance, regulatory folder set up, direction
on recruitment, consenting, and data collection.
Duties include, but not limited to:
Provide clinical research support including but not limited to,
knowledge management and communication activities, recruitment,
randomization, data collection, tracking, interviews, follow-up and
technical reports necessary to conduct research studies in
accordance with approved protocols, and applicable Air Force, DHA,
DoD, Department of Veterans Affairs and Federal Regulations while
promoting the safety, welfare, and confidentiality of research
subjects and ensuring the integrity of data at all times.
Specific tasks include:
Provide administrative support to include the collection,
compilation, and documentation of research data, in accordance with
the details outlined in the research protocol for a given study and
in according with HIPAA guidelines.
Assist Principal Investigator in identifying recommended protocol
changes as needed.
Advertise for the assigned studies utilizing the approved
recruitment materials. Draft new recruitment materials and identify
new avenues for recruitment as needed.
Provide support to plan and organize technical and consultative
Liaise regularly with the Clinical Investigations Program to keep
abreast of current clinical research protocols and regulations;
attend their department meetings as appropriate.
Meet with potential research subjects; explain the research project
in detail, independently judge suitability of research
participants, review subject inclusion/exclusion criteria, and
recruit eligible subjects into the study by obtaining written
informed consent and HIPAA Authorization, ensure Principal
Investigator signs inclusion/exclusion prior to entering research
subject into the study.
Serve as point of contact for research subjects; schedule research
visits, clinic room time and other services where needed.
Obtain research data through interviews with research subjects,
administer and scores questionnaires, extract information from
paper or electronic records in accordance with approved research
protocols, maintain study codes, organize research data for
analysis by a statistician.
Maintain integrity of data within data collection tools,
spreadsheets and databases. Monitors and evaluates procedure data.
May develop system for Quality Assurance/Quality Control (QA/QC)
checks; performs QA/QC checks.
Assist in ensuring quality of project deliverables to include
providing study-specific information and patient success
Assist with formal audits and coordinate with study auditors,
regulatory agencies, collaborators, and sponsors in management of
Monitor research subjects' progress to include documentation and
reporting of adverse events to the Medical Monitor or Data Safety
and Monitoring Board, sponsor, and the Institutional Review Board.
Recommend corrective action as appropriate.
Identify delays and other shortcomings in meeting objectives and
study recruitment goals, develop a contingency plan as needed.
Ensure compliance of general and study specific regulatory
processes across multiple studies of different therapeutic areas
and phases, in accordance with the details outlined in: research
protocols, applicable Standard Operating Procedures, Food and Drug
Administration regulations, Air Force Instructions, Defense Health
Agency (DHA) directives, DoD Directives, MDG Instructions,
Department of Veterans Affairs regulations, Institutional Review
Board (IRB) specific regulations, Office for Human Subject Research
Protections, The Declaration of Helsinki, The Belmont Report,
National Institutes of Health (NIH) guidance and Good Clinical
Perform light duties and other related duties as required and
Assists CIP Director in various tasks.
Maintain a safe workplace; observes appropriate safety and
occupational health rules and regulations. Employee is required to
attend safety and other training relative to his/her position and
report infractions of safety procedures to the facility Safety
Officer. Must obtain and maintain CITI training and annual Human
Subject Research Protection training in accordance with IRB
Bachelor's Degree or Certification in Clinical Research and 2 years
healthcare related field experience or experience in human
research, development, test, and evaluation (within the last five
Must have current Human Subject Research Protection training Office
of the Under Secretary of Defense "Personnel and Readiness".
Must have current Basic Life Support (BLS)
Experience assisting with acupuncture research preferred.
Experience working within the Military Medical system (e.g., as
military, civilian employee or government contractor)
Must be detail oriented and able to work independently following a
brief period of specific technical training.
Available to travel in order to provide services, receive
specialized training, and/or coordinate between research sites when
it's in the best interest of the Government.
Able to read, write, and speak English fluently in order to
effectively communicate with all personnel eligible for medical
care and the staff of the military medical treatment facility
(MTF). Have the ability to enunciate with sufficient clarity to be
readily understood by patients and staff.
Sufficient initiative, interpersonal relationship skills and social
sensitivity such that they can relate constructively to a variety
of patients and staff from diverse backgrounds.
Excellent time management and communication skills; able to work in
a team environment and concurrently support several active clinical
Proficient with office equipment (e.g., computers, multi-line
telephone system, voicemail, facsimile, copier, printers), as well
as business software for word processing, presentations,
spreadsheets, database management, and email communications. This
includes, but is not limited to, Microsoft Office 2003 (i.e., Word,
Excel, PowerPoint, and Outlook).
Odyssey Systems Consulting Group, is an innovative small business
committed to providing world-class technical, management, and
training support services to government and public sector clients.
We focus on people, processes, and performance to deliver superior
results. Since our inception in 1997, our commitment to mission
success and customer satisfaction has been recognized with
exponential growth and exceptional past performance ratings. We
accept challenging assignments and drive projects from the planning
stages, through implementation, and into operations and
Equal Opportunity Employer/Protected Veterans/Individuals with
Keywords: Odyssey Systems Consulting Group, Ltd., Las Vegas , Clinical Research Coordinator, Healthcare , Las Vegas, Nevada
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