Clinical Research Coordinator (Center for Neuroscience and Regenerative Medicine)

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Updated: June 16, 2018
Job ID: 213930
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a Clinical Research Coordinator to support the Center for Neuroscience and Regenerative Medicine (CNRM) Acute Studies Core at the National Institutes of Health (NIH) Clinical Center, Bethesda, Maryland.  HJF provides scientific, technical and programmatic support to CNRM.

The incumbent will participate in a multi-institutional traumatic brain injury (TBI) research group that includes physicians, nurses, and scientists at the National Institutes of Health, Washington Hospital Center, Suburban Hospital, and Uniformed Services University. Responsibilities include the coordination of clinical study participation, data collection, and assuring that accurate study documentation is maintained and complies with all governing regulations.

Responsibilities:

  1. Oversee operating procedures related to the conduct of the studies (i.e. recruitment, informed consent procedures, visit coordination, data collection, data verification, study monitoring, and regulatory reporting)
  2. Develop or improve systems of data collection, verification and management
  3. Data collection validation and analysis, including regular internal audits of collected data at the sites
  4. Responsible for regulatory aspects of studies
  5. Maintain communication with IRBs and take lead in reporting adverse events, protocol deviations, and other items as directed by GCP and IRB guidelines
  6. Maintain regulatory binder, investigator’s file, and related documentation
  7. Develop, implement, and maintain reporting mechanism for bringing high priority issues to investigators, CNRM, study monitors, and regulatory bodies.
  8. Work in collaboration with study team to ensure study preparedness
  9. Point of communication between site study staff and Acute Studies Core Project Manager and Investigators
  10. Serve as point person for site monitoring needs
  11. Develop and maintain study site specific protocol documents
  12. Provide support for the development of case report forms (CRFs) and implementation of electronic CRFs.
  13. Schedule and conduct training as needed for staff
  14. Participates in special projects as needed.

Required Knowledge, Skills, and Abilities:   Knowledge of complex clinical research procedures; excellent interpersonal and computer skills; ability to communicate effectively and to work with individuals of all levels

Minimum Education/Training Requirements:  Bachelor’s Degree in related field; nursing, psychology, public health, or neuroscience. CRC certification preferred.

Minimum Experience:  0 to 2 years clinical research experience to include regulatory compliance and filing.

Physical Capabilities:  Long periods of standing; some bending, lifting, and walking

Supervisory Responsibilities/Controls:  May supervise administrative staff working on the research projects.

Work Environment:  Laboratory or clinical/hospital environment.

Background: Must be eligible to obtain and hold NIH background and National Agency check.

Travel/Location:  Position requires frequent travel to study sites as required to include Suburban Hospital approximately twice a week, Washington Hospital Center approximately twice a week and NIH and/or the Uniformed Services University (USU) as required.

Work Schedule: Work schedule will include some early evenings and weekend days (< 20%) in order to meet the needs of study recruitment and follow-up visits.

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

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