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Clinical Research Coordinator

Company: Odyssey Systems Consulting Group, Ltd.
Location: Las Vegas
Posted on: May 4, 2021

Job Description:

Position Summary

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.

Responsibilities

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 meetings.
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 stories.
Assist with formal audits and coordinate with study auditors, regulatory agencies, collaborators, and sponsors in management of research studies.
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 Practices.
Perform light duties and other related duties as required and assigned.
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 policy.


Qualifications

Education

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 years).
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

Experience assisting with acupuncture research preferred.
Experience working within the Military Medical system (e.g., as military, civilian employee or government contractor) preferred.
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.


Knowledge

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 research projects.



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).



#LI-MN1

Company Overview

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 support.



Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Keywords: Odyssey Systems Consulting Group, Ltd., Las Vegas , Clinical Research Coordinator, Healthcare , Las Vegas, Nevada

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