Clinical Research Consultant

WHAT I DO...

I offer a variety of services to my clients including:

• STUDY DOCUMENT DEVELOPMENT

  Assistance with developing study documents, for example Subject information leaflet and Informed Consent Form, DSMB and CEC charters, (e)CRF, monitoring manual, screening and enrolment logs, or clinical study report.

• EC AND REGULATORY SUBMISSIONS

  Submitting your initial clinical trial application or study amendment to the Central Ethical Committee, the Competent Authority, and/or work with the Investigator on submitting to the local Board of Directors. I can also assist in completing the required documentation (EudraCT, ABR form, etc.).

• STUDY STARTUP

  From site selection visit to initiation visit, I can assist with study startup. We can discuss what tasks you want to delegate to me, so I can step in where needed.

• SITE CONTRACT AND BUDGET NEGOTIATION

  Finalising the Clinical Trial Agreement and site budget negotiations can be a complicated process. I can work with you to make this process go as smooth as possible.

• CRA TRAINING

  Training of junior CRAs, training on the job, study specific training, and/or SOP training. Ask for the possibilities.

• ROUTINE MONITORING

  Routine monitoring: on-site visits (initiation, monitoring and close-out) and remote (centralized) monitoring, all accompanied with adequate reporting and follow-up. I can also assist in developing the monitoring plan for your study.

Also contact me for non-obvious positions.