Clinical Research Coordinator I

Summary of Responsibilities

The Clinical Research Coordinator will assist in the management of clinical studies and/or parts of studies with supervision. The Coordinator will be responsible for providing support for clinical study activities and procedures. Duties also include execution of experimental protocols and specimen processing.

Job Type: Full-time, Exempt

Essential Duties and Responsibilities

  • Assist with clinical research activities and study management.
  • Assist with regulatory affairs documentation and submissions.
  • Liaison with Clinical Services, Medical Director, Veterinary Director, and Clinical Consultants to streamline special test requests and results delivery.
  • Responsible for process of sample de-identification, coding, blinding and randomization for FDA and IRB compliance in clinical research.
  • Coordinate human and veterinary clinical trials and other studies with collaborating institutions and prepare associated documentation.
  • Specimen processing, storing, shipping and sample set preparation/documentation.
  • Ensure work is aligned with all relevant quality requirements.
  • Adhere to safety SOPs and report potential safety hazards.
  • Must be able to work productively and independently in an interdisciplinary team environment.
  • Other duties as assigned.

Qualifications

To meet standards of this position, personnel must be able to perform each essential duty satisfactorily.

Skills, Specialized Knowledge and Abilities

  • Must be able to work productively and independently in an interdisciplinary team environment.
  • Basic knowledge of research principles and Good Clinical Practice (GCP).
  • The candidate should have experience with protocol development and the ability to grasp basic scientific study design and regulatory principles related to the products being evaluated in the course of the clinical research.
  • Basic knowledge in the areas of microbiology, immunology or molecular biology and biochemistry preferred.
  • Strong skills in database management.
  • Strong attention to detail and problem solving abilities.
  • Must possess exceptional communication (written and verbal), interpersonal and problem solving skills.
  • Computer proficiency (Microsoft products)
  • Highly motivated, readily adapts to changing priorities, effectively manages own time to ensure tasks, multiple projects are completed on time.

Education and Experience

  • B.A. or B.S. in Biology, Microbiology, Biochemistry or other Scientific Field or pertinent experience preferred.
  • Minimum of 3 years pertinent industry experience preferred.

Apply today for the Clinical Research Coordinator I position at MiraVista Diagnostics in Indianapolis. Please use the form on the website Career Center (or email your resume to careers@miravistalabs.com if you have any problems with the web form).

MiraVista was founded in 2002 by Dr. Lawrence Joseph Wheat, whose groundbreaking research resulted in the development of the first histoplasmosis antigen test. Today, MiraVista serves the medical and healthcare sectors in the U.S. and Canada by processing over 100,000 tests per year for fungal infections and continuing both clinical research and test development. These include antigen and antibody detection tests for diagnosing coccidioidomycosis (valley fever fungus), aspergillosis, histoplasmosis, blastomycosis and cryptococcosis. MiraVista’s team of experienced infectious disease specialists and scientists have collectively published more than 1,000 scientific research articles.

MiraVista Diagnostics is an Equal Opportunity Employer.

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