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Clinical Research Coordinator

2 months ago

Rockville, United States LMR Technical Group Full time
Job DescriptionJob DescriptionSalary:

LMR Technical Group (LMR) is seeking a Clinical Research Coordinator.


Location: Rockville, MD. Teleworking eligible.


Job Description: The Clinical Research Coordinator will independently provide support services to satisfy the overall operational objectives of the National Cancer Institute, Division of Cancer Epidemiology and Genetics. The primary objective is to provide services and deliverables through performance of support services.


Duties and Responsibilities:

  • Supports clinical staff develop, implement and maintain clinical research data files and materials.
    • Assist preparing and submitting for review accurate source documents related to all research procedures.
    • Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
    • Participate in developing and maintaining research protocol documentation and operations.
    • Assist researchers with study testing, observations data entry and other duties associated with study sessions.
  • Collects research data and prepares information for inputs and analysis.
    • Verify study participant information and collect data and results of testing.
    • Assist staff develop, assemble related documentation and maintain regulatory binders for all protocols.
    • Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.
      - Set up, format and enter data into spreadsheets to analyze information and create reports.
    • Enter data into research databases, systems and applications for ongoing studies.
    • Documents, collects, records, and retains all research related participant encounters including in person, phone, or electronic in
      the research record e.g., source documents, case report forms according to regulations, guidelines, and institutional specific policies,
      including ensuring good documentation practices for all documents.
    • Anticipate and consistently meet reporting deadlines, collaborating with PIs and teams to note data trends and identify problems
    • Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures
      and regulatory processes and considerations.
    • Assists the research team with data extrapolation, entry, cleaning, and overall quality assurance of incoming and historical data
    • Verifies study participant information and collects data longitudinally
  • Supports the development of forms and questionnaires.
    • Assist researchers develop, maintain and complete study data collection forms and source documents.
    • Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.
    • Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes/summaries.
    • Organize, prepare and distribute informational materials and provide support to the educational mission of the study to both the study
      team as well as participants.
    • Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging
      trends in clinical studies, new literature and findings and regulatory considerations.
  • Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
    • Retrieve research related information from medical records, hospital information system and laboratory information system and create
      spreadsheets and other reports for use in study analysis.
    • Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.
    • Assist researchers with the collection and analysis of research data and samples.
  • Monitors subject's progress and reports adverse events.
    • Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.
    • Update and maintain logs and records of patient and family contacts.
    • Maintain the privacy and confidentiality of participant and research data; Protects participant, protocol, and scientific confidentiality by
      ensuring security of research data and personal health information.
    • Assists with managing and retrieving data from the electronic medical record system at the NIH Clinical Center (CRIS), dissemination
      of surveys, and data collection from participants.
  • Supports assembly, development and review of new research projects.
    • Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol
      deviations, and Safety Letters in accordance with local and federal guidelines.
    • Assist researchers obtain IRB approval before any study related activities begin.
    • Assist key research personnel ensure that clinical research activities are performed in accordance with federal, state and institutional
      regulations, policies and procedures.
    • Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and
      procedures.
    • Assist researchers develop and maintain current and new research protocols.
    • Research changes and updates to Good Clinical Practices (GCP) and prepare summaries, job aids and training materials for research
      staff and new clinical research coordinators.
  • Supports the creation and management of clinical websites and web-based tools.
    • Maintain content on the Clinical Studies websites (resources for staff and extramural investigators).
    • Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol
      tracking and management databases system.
    • Provide quality and detailed feedback on the development of new study and data management features.
  • Deliverables. Upon request, the contractor shall provide documentation evidence of any and/or all work product, including, but not limited to, the following tasks:
    • Work products and documents related to managing branch projects and data; coordinating epidemiologic study implementation and data collection.
    • Work products and documents related to designing and supporting analysis of questionnaires, surveys, protocols, informed consent documents, training manuals, SOPs, and database management systems.
    • Work products and documents related to managing IRB submissions for branch protocols.
    • Work products and documents related to preparing data summaries, organizing and enhancing websites. - Ad-Hoc
  • Other related duties as assigned


Basic Qualifications:

  • Bachelor's degree in a medical health field of study.
  • Certification as a Clinical Research Coordinator (CRC).
  • Experience with ServiceNow, MS Office, Qualtrics, and Medidat software.
  • Experience in clinical research.
  • Ability to work independently and function within a team with strong attention to detail.
  • Reliable and able to prioritize competing responsibilities.
  • Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future.


Preferred Qualifications:

  • Prior experience working with the National Institute of Health (NIH).


*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.  


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


LMR's Benefits Plan Includes:

  • Medical, Dental, and Vision Insurance
  • Life and Disability Insurance
  • 401(k)
  • Paid Time Off
  • Paid Holidays
  • Employee Assistance Program

 

About LMR:

LMR is a service-disabled veteran-owned small business that supports technology development and provides comprehensive joint warfighter training by leveraging the skills, experience, and knowledge of its personnel.  Our team consists of personnel with diverse backgrounds.

 

LMR is an equal opportunity organization. We recruit, employ, train, compensate, and promote without regard to race, religion, color, national origin, age, gender, sexual orientation, gender identity, marital status, disability, protected veteran status, or any other basis protected by applicable federal, state or local law.


LMR will not discriminate against persons because of their disability, including disabled veterans, and will make reasonable accommodations for known physical or mental limitations of qualified employees and applicants with disabilities. If you are interested in applying and require special assistance or accommodations due to a disability, please contact our Human Resources department at hr@lmrtec.com.


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