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8110 Gatehouse Road, Falls Church, VA 22042

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Clinical Research Nurse Coordinator 1

Fairfax Medical Campus 623190 Full Time 3300 Gallows Road, Falls Church, VA, 22042, US
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Job Description

Inova’s  Women's Research department is seeking a Full Time Clinical Research Nurse Coordinator 1 to join their team.

The Clinical Research Nurse Coordinator I (CRNC I) is a competent clinician who utilizes the nursing process and current clinical knowledge to provide professional nursing care in the context of research study coordination and care. The CRCN I acts as study coordinator for assigned studies and assesses, plans, implements and evaluates patient’s physical, learning and psychosocial care. The CRCN I coordinates clinical drug and device study protocols using diverse clinical assessment and administrative skills and knowledge, to ensure that the appropriate data is compiled and reported, protocol and regulatory requirements are met, and study participants follow correct steps. The CRCN I interacts with sponsors, research team members, physicians and study patients. Conducts study protocols in accordance with sponsor requirements, FDA, state regulations and Inova policies and procedures. The CRCN I provides appropriate clinical assessment of the study patients to provide quality care throughout the study and follow up period. Confidentiality and accuracy of all study records will be ensured.

The CRNC I will develop a basic level of understanding of study coordination and the ability to perform a variety of tasks under direct supervision. It is anticipated that the entry level CRNC I will be exposed to and have the opportunity to demonstrate their competencies across several different types of clinical studies (investigational products, study phases, therapeutic areas and indications). The CRNC I will maintain all required credentialing and comply with continuing education requirements relevant to nursing and as required by regulation and policy

Job Responsibilities:

  • Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment.
  • Utilizes clinical experience and skills to delineate and define the physiological status of the patient. In addition, utilizes the skills to assess the educational, psychological and spiritual needs of the patient/significant other/family.
  • Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects; notifies treating investigator of findings/issues.
  • Performs nursing duties as assigned and relevant to credentials and research study needs.
  • Identifies and explain key protocol elements and perform study tasks under direct supervision.
  • Explains basic elements of subject safety including reasoning behind required use of an Institutional Review Board/Independent Ethics Committee, study activity documentation, and event reporting requirements. Demonstrate subject protection under direct supervision.
  • Explains the investigational products development process and identify key regulations to control these processes.
  • Explains and performs study operational activities in compliance with Good Clinical Practice (GCP).
  • Explains and performs non-GCP related study management activities.
  • Explains how to document data according to ALCOA-C (Attributable, Legible, Contemporaneous, Original, Accurate and Complete) principles.
  • Explains the importance of professional conduct and describe leadership principles that impact the effective operation of an investigative site.
  • Explains the variety of communication channels, roles and relationship and outlets for study results that impact the conduct of clinical research.

Qualifications:

  • One year of nursing experience preferred

Education

  • Bachelor's degree; proficiency in English

Licensure:

  • Active Virginia RN license

Certification

  • BLS Certification