Clinical Research Associate II

Pfm; United States; Remote; USD 56,000 - 78,000; Full time

Benefits offered by this job

Remote work option

Job summary

Precision Medicine Group in the Netherlands seeks a Clinical Research Associate II to monitor studies at investigative sites, ensuring compliance with protocol, SOPs, ICH-GCP and applicable regulations.

This remote-based role requires biopharma monitoring experience, flexibility for travel, and fluency in English and Dutch; French is a plus. You will work with a passionate team in a smaller CRO that values input and impact.

Qualifications

• Life science degree required.
• 2+ years as a CRA in CRO or pharma/biotech industry.
• Willingness to travel domestically and internationally (up to 50-60% travel).

Responsibilities

• Monitor progress of clinical studies at investigative sites per protocol and ICH-GCP.
• Coordinate all activities to set up and monitor a study (identify investigators; regulatory submissions; pre-study visits; initiation visits).
• Identify study risks and propose mitigation strategies to ensure quality and outcomes.

Skills

Communication skills

Organizational skills

Client-focused approach

Fluency in English and Dutch

Willingness to travel

Education

Life science degree

2+ years CRA experience

Job description

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will have a lower than average number of protocols, setting you up to be a protocol expert. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a smaller CRO allows you to have influence and impact when it matters most and support from direct line management.

We are now recruiting Clinical Research Associate II to join our team in the Netherlands. This is a remote based position with travel to sites for morning visits. We are looking for candidates in the Netherlands with biopharma monitoring experience.

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:

• Life science degree and / or equivalent experience
• 2 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.
• Availability for domestic travel including overnight stays, as required (international travel may be required for some senior level positions)

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, Dutch
• French will be a plus
• oncology monitoring experience will be a plus

Preferred:

• Study start up activities experience.

Please apply in English.

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