Clinical Research Assistant

2 weeks ago

Fayetteville, Georgia, United States Javara Full time

*** We are seeking individuals with experience comparable to a Certified Medical Assistant (CMA); active certification is not mandatory (Registered Medical Assistant (RMA) is also acceptable). This role is designated as Clinical Trial Navigator I, as detailed in the following description. This position requires on-site presence.

Overview:

As a Clinical Trial Navigator I at Javara, you will play a pivotal role in the coordination and management of clinical trials, reporting directly to the Manager of Site Operations and the Principal Investigator or their designee. You will be an essential contributor to our organization, aiding in patient enrollment across various clinical studies. With a primary focus on ensuring the safety of research participants, you will implement and oversee research study protocols for the effective administration of clinical trials.

Key Responsibilities:

  • Enhance the patient experience while maintaining uncompromised safety standards.
  • Deliver exceptional customer service to patients, participants, healthcare partners, investigators, sponsors, and vendors.
  • Act as the lead Clinical Trial Navigator for at least one clinical study, taking ownership of the enrollment strategy and execution.
  • Implement the enrollment strategy for assigned studies to meet target goals by identifying and engaging potential participants and screening them for suitable studies.
  • Foster strong working relationships with colleagues, patients, investigators, and other internal and external stakeholders involved in clinical trials.
  • Support enrollment objectives by contributing to patient retention initiatives and building connections within local communities.
  • Ensure the scientific integrity of data by accurately recording source data, including patient visit information, within various reporting systems, and resolving queries promptly.
  • Maintain up-to-date study documentation that is audit-ready, including the reporting of adverse events and deviations related to investigational products.
  • Comply with all Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), protocols, OSHA regulations, and other relevant authority requirements.
  • Conduct and document the informed consent process.
  • Educate the research team and healthcare system staff on study-related procedures, including investigational product dosing and monitoring requirements.
  • Coordinate and schedule patient visits, ensuring adherence to study protocols.
  • Effectively communicate and escalate issues to ensure responsiveness and resolution with healthcare partners and external stakeholders.
  • Perform clinical and laboratory tasks, including obtaining vital signs, conducting EKGs, phlebotomy, and managing bodily samples.
  • Exhibit awareness of the immediate impact of your role on clinical trials.
  • Embody our Core Values by promoting teamwork, collaboration, and relationship-building with healthcare representatives.
  • Complete additional tasks as assigned.

Qualifications:

  • Associate's or Bachelor's Degree in a related field or equivalent industry experience.
  • Minimum of 1 year of experience in healthcare or a related field, demonstrating hands-on application of clinical functions such as obtaining vital signs, performing EKGs, and conducting phlebotomy.

Work Environment:

The characteristics of the work environment described here are representative of those encountered while performing the essential functions of this role.

  • This position operates within a professional setting.
  • The noise level in this environment is typically light to moderate.

Physical Demands:

The physical demands outlined here are representative of those necessary to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to fulfill these functions.

  • Regular use of hands to reach, handle, or feel objects, tools, or controls, along with the ability to talk and hear.
  • Frequent standing, walking, and sitting.
  • Occasional lifting and/or moving of up to 25 pounds.
  • Specific vision abilities required include close vision, distance vision, and the ability to adjust focus.

Pre-Employment Screening: Drug screening and background checks are required.

This job description encompasses the essential functions of this position and is not intended to provide a comprehensive list of activities, duties, or responsibilities required of the employee in this role. Duties, responsibilities, and activities may change at any time with or without notice.

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