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Clinical Research Consultant
Freelance Sr. CRA / Lead CRA with broad experience;
hands-on, can-do attitude; having oversight whilst keeping attention to details
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.
ABOUT CRA+
CRA+ is the name of the company owned by me, Karen Noorlander. In 2008 I started working in clinical research, since 2015 I work as an independent clinical research professional. My company is registered with the Chamber of Commerce (KvK) number: 64294706, and is VAT registered. I work with companies developing (bio)pharmaceuticals, medical devices or nutrition or CROs to consult on and assist with a variety of tasks within the clinical research field. All my activities are performed with clear communication and efficient reporting to my clients, including follow-up.