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Senior Clinical Research Monitor - Remote

Company: Vitalief Inc.
Location: Garland
Posted on: November 25, 2022

Job Description:

Why Vitalief?Vitalief, a fast-growing, innovative Clinical Trial Solutions Company, is committed to identifying talented and passionate clinical research professionals to join our exceptional team as experts and active members of our clients' research efforts.
Our PEOPLE FIRST culture prioritizes personal and professional growth for OUR team. Although unconventional, we believe this is the right approach to attract and retain top clinical research talent. We offer the flexibility, growth, and professional support that the highly competitive clinical research industry demands.
None of this is possible without the drive and passion of our Vitalief team members. If you are interested in the clinical research profession and being part of a culture that includes:

  • The ability to create and pursue multiple career paths
  • Meaningful work in a flexible work environment
  • An innovative culture that respects and encourages your voice
  • Transparent leadership that invests in your career progression
  • Variable incentive/reward system
  • Mentor/mentee opportunities and support programs designed to help you achieve your professional goals
    Then we want to speak with you!
    Note: Work is 100% remote in Texas
    Responsibilities:
    • Under the supervision of the Director, Protocol Support and Management, you will be responsible for the review and evaluation of multicenter clinical trial conduct, executing monitoring and site management activities to ensure compliance to the protocol and applicatory guidelines and regulations.
    • Developing and maintaining collaborative study site relationships to drive site performance and overall clinical trial safety and success from site initiation, study start-up, maintenance, and close-out.
    • Participates in the development of and/or review of study related documents (Protocol, Informed Consent, CRFs, Monitoring Plan, etc.).
    • Conducts qualification, site initiation, routine monitoring, and termination visits, performs data review and monitors data quality. Generates reports summarizing findings to ensure timely query and action item resolution.
    • Mentors, coaches, and trains junior team members. Functions as a resource for project team members.
    • Generates and presents key metrics and reports to senior management, ensuring project milestones are met.
    • Exhibits core values of Caring, Integrity, and Discovery Behaviors.
      Required Skills:
      • Minimum of 7 years of experience to include five years of nursing and two years monitoring complex oncology trials.
      • Bachelor's Degree in Nursing, Healthcare Administration or related field required, Advanced degree preferred.
      • Strong, in-depth knowledge of FDA regulations and ICH/CGP.
      • Demonstrated ability to manage multiple multicenter studies.
      • Strong written and verbal communication skills; ability to interact professionally and effectively communicate at all levels.
      • Working knowledge of EDC systems and CTMS preferred
      • Proficiency with Microsoft Office suite
      • Preferred certifications include: Advanced Oncology Certified Nurse, Oncology Certified Nurse, Certified Clinical Research Coordinator, Certified Clinical Research Associate, Certified Clinical Research Professional, Regulatory Affairs Professional.
        PHYSICAL DEMANDS: Standing, sitting, walking, and reaching. Lifting, pushing and pulling up to 10lbs. Use of computer/keyboard.
        IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that requires all on-site resources such as prospective Vitalief consultants to provide proof that they are fully vaccinated for Covid-19; inoculated annually for Influenza; and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

Keywords: Vitalief Inc., Garland , Senior Clinical Research Monitor - Remote, Healthcare , Garland, Texas

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