Clinical Research Nurse

4 days ago

Dallas, Texas, United States Medix™ Full time

Clinical Research Nurse - Dallas, TX

Pay: $ $45/hour

Hours: M-F, 8-5

Format: 6 month, contract-to-hire

Position Summary:

The Clinical Research Nurse is responsible for overseeing and executing clinical studies in compliance with FDA, CFR, and ICH regulations and guidelines. This position plays a key role in managing all phases of clinical trials, from startup through closeout, ensuring accuracy, integrity, and regulatory compliance in every aspect of study operations.

Key Responsibilities:

  • Conduct clinical trials from feasibility through closeout in accordance with regulatory standards and study protocols.
  • Coordinate and facilitate communication between investigators, sponsors, and internal departments to support efficient study startup and timely enrollment.
  • Maintain comprehensive knowledge of study protocols to ensure all procedures and assessments are completed accurately.
  • Provide training to site personnel and clinical staff on study-specific requirements, regulatory expectations, and sponsor guidelines.
  • Educate study participants and their families on protocol procedures and the relationship of the study to their health condition.
  • Serve as a liaison between the research site, sponsors, IRBs, and regulatory authorities regarding study conduct and data integrity.
  • Prepare and maintain essential regulatory documentation, including IRB submissions, informed consent forms, protocol amendments, adverse event reports, and recruitment materials.
  • Develop and implement recruitment strategies to meet enrollment goals within target timelines.
  • Screen, consent, and register study participants according to inclusion and exclusion criteria.
  • Schedule and conduct study visits, ensuring all procedures and assessments are performed as required.
  • Provide after-hours and weekend availability for participant registration as needed.
  • Complete Case Report Forms (CRFs) accurately and within required timeframes.
  • Maintain detailed and compliant source documentation and case histories for each study participant.
  • Record and report all observations, adverse events, and protocol deviations in accordance with GCP and ICH standards.
  • Track, document, and reconcile investigational product and study supply inventory.
  • Safeguard participant safety and confidentiality at all times.
  • Obtain informed consent from participants prior to study procedures.
  • Follow electronic source documentation and certification protocols to ensure data accuracy and security.
  • Maintain regulatory binders and essential documents for audit readiness and inspection compliance.

Professional Development:

  • Maintain required clinical certifications, including RN licensure and BLS certification.
  • Complete ongoing training in Good Clinical Practice (GCP), Human Subjects Protection, and study-specific requirements.

Qualifications:

  • Registered Nurse (RN) or equivalent clinical background preferred.
  • Strong knowledge of GCP, ICH, and FDA regulations.
  • Excellent organizational, communication, and interpersonal skills.
  • Proven ability to manage multiple studies and competing priorities effectively.
  • Flexibility to work occasional evenings or weekends as study needs require.
  • Clinical Research experience
  • Associate's Degree of BSN
  • Cardiology experience is preferred

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