
Senior Clinical Research Associate
Key Skills
Job Description
Company Description
PSI is a leading Contract Research Organisation with 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.
This is a home-based position.
Your responsibilities will include:
- Conducting and reporting all types of onsite monitoring visits
- Driving the study startup phase
- Performing CRF reviews, source document verification and query resolution
- Be responsible for site communication and management
- Supervising study activities, timelines, and schedules for each site
- Acting as a point of contact for in-house support services and vendors
- Supporting quality control, such as compliance monitoring and reports review
- Participating in feasibility research
- Supporting the regulatory team in preparing documents for study submissions and regulatory approval
Qualifications
- BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
- Independent on-site monitoring experience in the Netherlands
- Demonstrable experience in all types of monitoring visits in Phase II and/or III
- Strong written and verbal communication skills
- Fluency in Dutch and English
- Experience supporting Oncology studies is beneficial, but not essential
- Advanced knowledge of MS Office
- Full and clean driver's license, and the ability to travel
- Communication, collaboration, and problem-solving skills are essential
- Ability to multitask and work in a dynamic team environment
Additional Information
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
As a Senior CRA in the Netherlands, you will also be part of our growing local team, contributing to the continued development of PSI’s presence in the Netherlands while working closely with colleagues across the wider organization.
Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.
Core Responsibilities
The Senior CRA is responsible for conducting onsite monitoring visits, managing clinical sites, and ensuring data quality and compliance with study protocols. They also act as a primary point of contact for stakeholders and support regulatory document preparation.
Requirements
Candidates must hold a BSc or MSc in Life Sciences and possess independent on-site monitoring experience in the Netherlands. Proficiency in Dutch and English, along with a valid driver's license, is required.
Benefits
- Professional development
- Career growth opportunities
About PSI CRO
Industry: Pharmaceutical Manufacturing
Company size: 1,001-5,000 employees
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com