Clinical Research Associate II

About you:

• You are calm, thoughtful, and responsive when things don’t go as planned.
• You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
• You find quick and creative ways of overcoming difficulties.
• You have an impeccable eye for detail.
• You identify potential study risks and propose solutions on how to mitigate them.
• You take responsibility in the quality and outcomes of your work.
• You are adept at handling conflict by using tried and true resolution strategies.

How we will keep you busy and support your growth:

You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Qualifications:

Minimum Required:

• Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline
• 2,5 years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research.

Other Required:

• Excellent communication and organizational skills are essential. A team player.
• Evidence of a client focused approach.
• Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions)
• Fluency in English and for non-English speaking countries the local language of country where position based

Preferred:

• Experience with oncology studies will be a plus
• Study start up activities experience