Description

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
   conduct.
   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.

#LI-SK4

#LI-Hybrid

Qualifications