CRA - Janssen, Israel

Auris Health

Auris Health

Shefayim, Israel
Posted on Monday, August 28, 2023


Janssen - Be part of something great

Janssen is an international pharmaceutical company belonging to the Johnson & Johnson Group and is engaged in the development of breakthrough drugs in the medical world.

Guided by Johnson & Johnson’s Credo and values and with commitment to quality of life being at the forefront of its priorities, Janssen devotes considerable resources to developing drugs for the treatment of serious and life-threatening illnesses, as well as medicines that improve the quality of patients' lives.

The company is actively engaged in increasing awareness of various diseases and their therapeutic pathways, conducting educational and training activities for medical teams, and collaborating with various patient associations.

As Clinical Research Associate in our global clinical operations (GCO) you will:

  1. Acts as primary local company contact for assigned sites for specific trials.
    2. Participate in site feasibility and/or pre-trial site assessment visits
    3. Attends/participates in investigator meetings as needed.
    4. Responsible for executing activities within site initiation and start-up, preparation and conduct of site
    monitoring (including remote monitoring), site management (by study specific systems and other
    reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
    Responsible for the implementation of analytical risk based monitoring model at the site level and to
    work with site to ensure timely resolution of issues found during monitoring visits.
    5. Ensures site staff are trained and the corresponding training records are complete and accurate at any
    time point during all trial phases. Responsible in close collaboration with LTM and central study team
    for the activities during site activation phase in order to speed up the process and activate the site in
    shortest possible timeframe.
    6. Contributes to site level recruitment strategy and contingency planning and implementation in
    partnership with other functional areas.
    7. Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial
    8. Ensures that clinical drug supplies are appropriately used, handled and stored and returns are
    accurately inventoried and documented.
    9. Arranges for the appropriate destruction of clinical supplies.




  • A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
    is required.
  • A minimum of 2 years of clinical trial monitoring experience is preferred, however, other relevant
  • Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and
    associated protocol specific procedures including monitoring guidelines.
  • Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight
    stay away from home.
  • Proficient in speaking and writing the country language and English. Good written and oral communication.

Janssen is an equal opportunity employer promoting diversity and inclusion in the workplace.

This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation.