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Clinical Research Coordinator

Rockville, MD

(ID: 2024-7005)


Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).


Axle is seeking a Clinical Research Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Cancer Institute (NCI) located in Rockville, MD.


Benefits We Offer:

  • 100% Medical, Dental & Vision Coverage for Employees
  • Paid Time Off and Paid Holidays
  • 401K match up to 5%
  • Educational Benefits for Career Growth
  • Employee Referral Bonus
  • Flexible Spending Accounts:
    • Healthcare (FSA)
    • Parking Reimbursement Account (PRK)
    • Dependent Care Assistant Program (DCAP)
    • Transportation Reimbursement Account (TRN)

Overall Position Summary and Objectives Under this task order the contractor 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.


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


Work Details:

  • Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures. 1
  • 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 2
  • Assists the research team with data extrapolation, entry, cleaning, and overall quality assurance of incoming and historical data 3
  • Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB). 4
  • 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. 5
  • 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.
  • 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.
  • 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
  • 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
  • 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 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.


1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked



Minimum Education

Bachelor


Additional Qualifications:

Certifications & Licenses
  • Clinical Research Coordinator (CRC)

Field of Study
  • Miscellaneous Health Medical Professions

Software
  • ServiceNow
  • MS Office
  • Qualtrics
  • Medidata

Skills
  • 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


Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.


The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.


Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com


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