linkedin.com/company/schutjens.com

About linkedin.com/company/schutjens.com

In more than 20 years, I have gained a lot of experience in clinical operations. All around processes, (e-) tools, people, teams, institutions, rules, regulations and do’s and don’ts. I bring this knowledge with me and I am happy to share it while I learn from others at the same time. I believe in development of organizations, teams and individuals. I also believe that this can happen when things are shared and discussed in a constructive way. I am an active ingredient for knowledge sharing and development. Services that I can provide: • Feasibility • Site selection • Pre-study visits • Initiation visits • Organization of start-up meetings • Monitoring visits (remote and on-site) • Drug accountability • Close-out visits • Set up and maintenance of the study file • CA submission • Central and local METC submission • Contract negotiation with sites and/or vendors • Writing of (country specific) patient information and informed consent • Writing /review of standard operating procedures • Design Study specific forms • Development patient recruitment plans • Audit preparation • GCP training, including European clinical trial directive and Dutch legislation • SOP training • Coaching • Co-monitoring and training visits

Keywords

• Clinical Research, Gcp, Training, Feasibilities, Cardiovascular, Neurology

Address

• Headquarters

  Verlengde Hoogeveensevaart7864 ZwinderenDrenthe, Netherlands