Senior Clinical Research Associate I

Job Description

As a Senior CRA I, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets. You will have the opportunity to work on clinical studies in various therapeutic areas and indications while maintaining the highest quality standards in the industry. This function operates at site and country level and can be assigned to projects as monitor or lead monitor.

Join the PSI team and help drive innovation and excellence in advancing healthcare solutions.

You will:

• Prepare, conduct and reports site selection, initiation, routine monitoring and close-out visits
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Act as a communication point between project teams and the site
• Leads project team calls on a country level
• Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions
• Prepare and participate in site audits and inspections

Qualifications

Office is located in Tokyo, Japan with Hybrid or remote work arrangement available. 

Applicants based in Osaka (or can come to Osaka office) are welcome to apply. 

• College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
• At least 3 years’ site monitoring experience at a CRA II or equivalent qualification level in Japan
• Experience in all types of monitoring visits in Phase II and/or III
• Experience in feasibility assessment and study set-up process is preferable
• Therapeutic area experience in Oncology /Hematology /Gastroenterology (IBD) /Infectious Diseases /Neurology/Renal is a plus
• Full working proficiency in Japanese and Intermediate English
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel up to 30% to 40%

Additional Information

How are we different?

PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.  

Being a Part of the Team

As a part of the PSI team, you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.

You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback.

Growth Opportunities

PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve.