Position Overview

Role involves designing and executing clinical research programs to enable successful transition to clinical development. The individual will get involved in the design, conduct, data management, and interpretation and reporting of clinical trials. This individual must ensure that all clinical studies operate to the highest ethical and safety standards and in compliance with company, GCP and regulatory requirements. Job duties:
  • Contributes to the preparation of study documentation such as protocols, amendments, Case Report Forms, SOPs, investigational plans, Investigator’s manual and study reports.
  • Collects and processes regulatory documents and correspondence.
  • Prepares and ensures accuracy for MV studies on clinicaltrials.gov.
  • Assumes other responsibilities under the direction of the Clinical Research Department.
  • Additional duties as assigned.

    1. Bachelor’s degree in related field or equivalent experience.
    2. Two (2+) years of direct clinical research experience, preferably in the medical device industry.
    3. IDE clinical experience is strongly preferred, as well as some global experience.
    4. Managerial skills with the ability to assign and monitor work.
    5. Strong verbal and written communication skills.
    6. MS office skills to include Word and Excel.
    Desired Qualifications
    1. Experience in designing, monitoring and implementing clinical trials and interpreting trial results, including understanding of biostatistics and safety reporting.
    2. Able to handle multiple tasks efficiently and consistently, meet deadlines.
    3. Detail-oriented.
    4. Ability to maintain strict confidentiality.